VELVALIZE fuses real-time bio-impedance spectroscopy, fluorescence-guided follicle detection, adaptive RF waveform modulation with a flexible pliers — delivering the most precise, permanent hair removal system ever engineered.
Adaptive Engine
Bio-Impedance Spectroscopy
Fluorescence Detection
Thermal Feedback
GSR Monitoring
Research & Development
The Science Behind VELVALIZE
Mission
Engineer the next generation of permanent hair removal by integrating adaptive electrolysis modalities (galvanic, thermolysis, blend) with multi-sensor closed-loop feedback — bio-impedance spectroscopy, fluorescence follicle-phase detection, spectrophotometric skin typing and MEMS thermal sensing — all orchestrated by on-device neural-network inference for real-time, per-follicle parameter optimization.
Vision
Establish VELVALIZE as the global reference standard in personalized, evidence-based permanent hair removal — advancing aesthetic dermatology and trichological science through reproducible, data-driven clinical outcomes with full regulatory traceability and predictive treatment analytics.
Clinical Advantages
Closed-loop adaptive RF modulation calibrated per follicle via real-time impedance, thermal and fluorescence sensing — targeting 20–30% reduction in treatment time with higher first-pass efficacy
Full DQRM-grade clinical traceability with automated session logging, parameter versioning, spectrophotometric skin-type records and audit-ready compliance documentation
Integrated micro-cryotherapy with GSR-driven pain modulation achieving 30–50% reduction in patient-reported VAS discomfort scores through TRPM8 cold-receptor pathway activation
Engineering Performance Targets
−20–30%
Treatment time
per follicle vs. conventional
−30–50%
VAS pain score
with CryoPulse + GSR
≤ 5%
Regrowth rate
at 12-month follow-up
>92%
First-pass efficacy
anagen-phase coagulation
<10 ms
Edge inference
on-device processing latency
Products & Solutions
A fully integrated ecosystem engineered from the ground up for evidence-based, sensor-rich, precision permanent hair removal
NovaBlend Console
Intelligent Electrolysis Platform
Multi-modality electrolysis console (galvanic DC / thermolysis HF / blend) with embedded bio-impedance spectroscopy, MEMS thermal array, fluorescence follicle-phase detection and spectrophotometric Fitzpatrick auto-typing — for real-time per-follicle waveform optimization.
Tri-modality output: galvanic DC, thermolysis HF (13.56 MHz) and blend with adaptive ratio control
UV fluorescence module (405 nm excitation) for anagen/catagen/telogen phase identification
On-device inference (Cortex-M7, <10 ms latency) for CNN follicle classification
Spectrophotometric sensor for automated Fitzpatrick skin-type classification (I–VI)
MicroProbe Flex
Smart Consumables
Single-use sterile filament probes with integrated MEMS thermistors, micro-impedance electrodes and passive UHF RFID for batch-level traceability. Engineered for simultaneous sub-dermal impedance measurement and precise energy delivery at the follicular target zone.
MEMS-integrated NTC thermistor (±0.1°C) for real-time tip-zone thermal monitoring
Dual micro-electrode ring for localized impedance measurement at insertion depth
Passive UHF RFID (ISO 18000-63) for lot traceability and NovaBlend auto-calibration handshake
Edge inference: Cortex-M7 runtime (<10 ms latency), medical-grade isolated DC supply with <50 mV ripple, Class IIa safety interlock, multi-channel 16-bit ADC at 10 kSps
Clinical software suite: practitioner dashboard, treatment planning with predictive analytics, session replay, DQRM documentation, remote supervision and AES-256 encrypted data export
Performance targets: −20–30% treatment time per follicle, −30–50% VAS pain score, ≤ 5% regrowth at 12-month follow-up, >92% first-pass coagulation rate
Bio-Impedance Spectroscopy
Multi-frequency impedance analysis (1 kHz–1 MHz) for real-time tissue characterization and closed-loop energy modulation
Swept-frequency excitation measures complex impedance |Z|, phase angle θ and Cole-Cole parameters (R₀, R∞, α, τ) to differentiate epidermis, dermis, sebaceous glands and follicular structures in real time
Closed-loop impedance tracking during energy delivery enables adaptive current modulation — automatically reducing power when tissue impedance indicates proximity to non-target structures
Pre-treatment impedance mapping correlates with stratum corneum hydration, sebaceous density and melanin concentration — feeding the spectrophotometric Fitzpatrick auto-typing algorithm
Precision Thermal Management
Dual-sensor topology with closed-loop PID control for dermal temperature regulation and patient safety
MicroProbe-embedded MEMS thermistor (±0.1°C NTC) monitors tip-zone temperature in real time, while CryoPulse surface thermopile tracks epidermal contact temperature
PID-controlled Peltier element maintains 8–12°C contact zone during energy delivery — targeting the thermodynamic boundary between effective follicular coagulation (>65°C) and patient comfort (<42°C at epidermis)
Thermal safety interlock: automatic power cutoff if tissue temperature exceeds programmable threshold (default 47°C) — hardware-level watchdog prevents thermal necrosis
Fluorescence-Guided Detection
UV-excited autofluorescence imaging for non-invasive hair-cycle phase identification before treatment
Narrowband 405 nm LED excitation induces tryptophan and porphyrin autofluorescence in the follicular matrix — emission spectra (420–600 nm) differ measurably between anagen, catagen and telogen phases
On-device spectral classifier (trained on 12K+ labeled follicle spectra) identifies anagen-phase follicles with >90% sensitivity
Pre-treatment fluorescence scan generates a color-coded follicle-phase map overlaid on the treatment zone — integrated with DermSense depth data for a complete 3D treatment planning view
Micro-electrode pair (Ag/AgCl, 8 mm diameter) integrated into the CryoPulse handpiece measures skin conductance (µS) at 100 Hz — electrodermal activity (EDA) as a validated psychophysiological proxy
Tonic SCL baseline established during first 30 seconds; phasic SCR peaks compared against baseline to compute a real-time comfort index
Adaptive feedback loop: when comfort index drops below threshold, system automatically increases CryoPulse cooling and/or reduces electrolysis energy amplitude
Spectrophotometric Skin Typing
Automated Fitzpatrick classification via broadband reflectance spectroscopy for protocol personalization
Broadband white-LED reflectance probe (400–700 nm) measures diffuse spectral reflectance R(λ) — melanin index (MI) and erythema index (EI) computed from characteristic absorption bands at 575 nm and 660 nm
Machine-learning classifier maps (MI, EI, L*a*b* colorimetry) to Fitzpatrick skin types I–VI with 96% agreement vs. expert dermatologist classification
Skin-type data feeds directly into the NovaBlend parameter engine: darker skin types (IV–VI) receive lower peak current and longer pulse duration to minimize epidermal risk
Peer-Reviewed Literature
Scientific Foundations
Peer-reviewed research and clinical literature underpinning VELVALIZE core technologies
Electrolysis & Hair Removal Science
Bono, F., Arias, M. · 2006
A comparative study of electrolysis modalities: galvanic, thermolysis, and blend for permanent hair removal
Journal of Dermatological Treatment · 17(4), 205–213
Foundational comparative analysis of the three electrolysis modalities (galvanic DC, thermolysis HF, blend) used in the NovaBlend Console tri-modality architecture.
Comprehensive review of physical hair removal methods supporting the clinical rationale for precision-optimized electrolysis over conventional approaches.
Definitive textbook on bio-impedance theory including Cole-Cole modeling (R₀, R∞, α, τ) and multi-frequency spectroscopy principles used in the NovaBlend impedance engine.
Martinsen, Ø.G., Grimnes, S., Schwan, H.P. · 1999
Interface phenomena and dielectric properties of biological tissue
Encyclopedia of Surface and Colloid Science · 20, 2643–2652
Foundational work on electrode-tissue interface impedance that guides MicroProbe Flex dual micro-electrode design for localized sub-dermal measurement.
Yamamoto, T., Yamamoto, Y. · 1976
Electrical properties of the epidermal stratum corneum
Medical & Biological Engineering · 14(2), 151–158
Seminal characterization of stratum corneum impedance properties — the basis for VELVALIZE pre-treatment impedance mapping correlated with skin hydration and melanin concentration.
Gillies, R., Zonios, G., Anderson, R.R., Kollias, N. · 2000
Fluorescence excitation spectroscopy provides information about human skin in vivo
Journal of Investigative Dermatology · 115(4), 704–707
Demonstrates the feasibility of in vivo UV-excited autofluorescence spectroscopy for skin characterization — the principle behind DermSense fluorescence-guided follicle-phase detection.
Kollias, N., Gillies, R., Moran, M., Kochevar, I.E., Anderson, R.R. · 1998
Endogenous skin fluorescence includes bands that may serve as quantitative markers of aging and photoaging
Journal of Investigative Dermatology · 111(5), 776–780
Establishes endogenous skin fluorophore signatures (collagen, elastin, NADH) that must be accounted for in VELVALIZE follicular phase classification to avoid false positives.
Machine Learning in Dermatology
Esteva, A. et al. · 2017
Dermatologist-level classification of skin cancer with deep neural networks
Nature · 542, 115–118
Landmark demonstration of CNN-level accuracy in dermatological image classification — the architectural precedent for VELVALIZE follicle-phase CNN classifier achieving 94% accuracy.
Foundational deep learning reference establishing the theoretical basis for convolutional neural networks deployed in the VELVALIZE edge inference engine.
Trends in Pharmacological Sciences · 33(6), 297–307
Establishes the TRPM8 cold-receptor pathway as a viable target for analgesic intervention — the neurophysiological basis for CryoPulse Comfort's pain attenuation mechanism.
Birder, L., Shieh, C.C. · 2008
Galvanic skin response and its correlation with clinical pain scores
Pain · 137(2), 403–413
Validates electrodermal activity (EDA) / galvanic skin response as a reliable objective proxy for perceived pain intensity — the psychophysiological basis for the VELVALIZE GSR comfort monitoring system.
Skin Typing & Spectrophotometry
Fitzpatrick, T.B. · 1988
The validity and practicality of sun-reactive skin types I through VI
Archives of Dermatology · 124(6), 869–871
Original Fitzpatrick skin type classification system (I–VI) that VELVALIZE automates via spectrophotometric broadband reflectance — replacing subjective visual assessment.
Spectroscopic characteristics of human melanins in vivo and in vitro
Journal of Investigative Dermatology · 85(1), 38–42
Defines optical absorption properties of eumelanin and pheomelanin in the 400–700 nm range — the spectral basis for VELVALIZE melanin index (MI) computation used in automated Fitzpatrick classification.
Disclaimer: The references listed above represent foundational peer-reviewed research in the scientific domains that underpin VELVALIZE technology. Inclusion does not imply endorsement by or affiliation with the cited authors or institutions. VELVALIZE products are in the R&D phase; clinical validation is pending.
Regulatory Framework
Regulatory Compliance & Certifications
Standards and certifications targeted for VELVALIZE medical device ecosystem
Quality Management
3 standards
ISO 13485:2016Targeted
Medical devices — Quality management systems — Requirements for regulatory purposes
Scope: Internationally recognized QMS standard specific to medical device manufacturers. Covers design controls, risk management integration, sterile product controls, supplier management and CAPA processes. Required by EU MDR, FDA QSR and Health Canada.
VELVALIZE application: Foundational QMS for VELVETZ INC. — covering NovaBlend Console firmware development under design controls, MicroProbe Flex manufacturing and sterilization, supplier qualification for Peltier elements and RFID components, and CAPA-driven continuous improvement across all product lines.
Medical devices — Application of risk management to medical devices
Scope: International standard for risk management throughout the medical device lifecycle. Covers hazard identification, risk estimation, risk evaluation, risk control and residual risk review. Mandated by all major regulatory frameworks.
VELVALIZE application: Risk management file for all VELVALIZE products — hazard analysis for HF thermolysis (tissue burns), bio-impedance electrode faults, CryoPulse overcooling, GSR sensor misreads and AI misclassification scenarios. Includes FMEA for safety-critical firmware modules.
Clinical investigation of medical devices for human subjects — Good clinical practice
Scope: GCP standard for planning and reporting of clinical investigations carried out on human subjects to assess the safety and performance of medical devices.
VELVALIZE application: Protocol framework for future VELVALIZE clinical trials — multi-site RCT design, informed consent procedures, adverse event reporting and statistical analysis plans for efficacy endpoints (regrowth rate, VAS pain score).
NovaBlend ConsoleCryoPulse Comfort
Electrical Safety & EMC
3 standards
IEC 60601-1:2005+A2:2020Targeted
Medical electrical equipment — General requirements for basic safety and essential performance
VELVALIZE application: Core safety standard for the NovaBlend Console power architecture — isolated DC supply design, Class IIa insulation coordination, protective earth continuity, leakage current limits and single-fault safety analysis.
Medical electrical equipment — Electromagnetic disturbances — Requirements and tests (EMC)
VELVALIZE application: EMC compliance for the NovaBlend console and CryoPulse module — ensuring low-ripple power supply does not emit interference affecting nearby medical equipment, and bio-impedance/GSR measurements are immune to ambient RF fields.
Medical electrical equipment — Particular requirements for HF surgical equipment and accessories
VELVALIZE application: Directly applicable to the NovaBlend Console thermolysis HF output (13.56 MHz) — patient circuit isolation, maximum output current/power limits, neutral electrode monitoring and HF leakage current compliance.
NovaBlend Console
Software & Cybersecurity
3 standards
IEC 62304:2006+A1:2015Targeted
Medical device software — Software life cycle processes
VELVALIZE application: Software lifecycle governance for the NovaBlend firmware (embedded inference engine, sensor acquisition, safety interlock logic), the clinical practitioner dashboard and the DermSense treatment planning algorithm — targeting Class C for safety-critical modules.
NovaBlend ConsoleDermSense Mapping
IEC 62366-1:2015+A1:2020Targeted
Medical devices — Application of usability engineering to medical devices
VELVALIZE application: Usability engineering for the NovaBlend practitioner interface — task analysis for treatment workflows, touchscreen UI risk assessment, alarm management design and summative usability validation with licensed electrologists.
NovaBlend ConsoleDermSense Mapping
IEC 81001-5-1:2021Planned
Health software and health IT systems — Security activities in the product life cycle
VELVALIZE application: Cybersecurity framework — AES-256 data encryption, secure firmware update mechanism, network segmentation for remote supervision, vulnerability disclosure process and SBOM management.
NovaBlend ConsoleDermSense Mapping
Biocompatibility & Sterilization
4 standards
ISO 10993-1:2018Targeted
Biological evaluation of medical devices — Part 1: Evaluation and testing within a risk management process
VELVALIZE application: Biocompatibility evaluation for MicroProbe Flex filaments (316L stainless steel, insulation coating) — direct tissue contact category, limited duration. Required testing: cytotoxicity, sensitization and irritation/intracutaneous reactivity.
MicroProbe Flex
ISO 10993-5:2009Targeted
Biological evaluation — Tests for in vitro cytotoxicity
VELVALIZE application: In vitro cytotoxicity testing of MicroProbe Flex filament materials — 316L stainless steel base alloy and polyimide insulation coating extracts evaluated against L-929 mouse fibroblast cell line per MTT assay.
MicroProbe Flex
ISO 11135:2014Planned
Sterilization — Ethylene oxide sterilization process development and validation
VELVALIZE application: Sterilization validation for MicroProbe Flex single-use probe packaging — EO cycle development, biological indicator (BI) placement, sterility assurance level (SAL) of 10⁻⁶ and residual EO degassing compliance.
MicroProbe Flex
ISO 11607-1:2019Planned
Packaging for terminally sterilized medical devices — Requirements for materials and sterile barrier systems
VELVALIZE application: Sterile barrier packaging design for MicroProbe Flex — medical-grade Tyvek/film peel pouch, seal strength validation, accelerated aging studies and transportation simulation per ASTM D4169.
MicroProbe Flex
Market Authorization
3 standards
EU MDR 2017/745Planned
European Medical Device Regulation
VELVALIZE application: CE marking pathway — Class IIa classification (Rule 9: active therapeutic devices delivering energy to the body), Notified Body audit, clinical evaluation report (CER) per MEDDEV 2.7/1 Rev.4 and EU declaration of conformity.
FDA Class II — Electrosurgical cutting and coagulation device (510(k) pathway)
VELVALIZE application: 510(k) premarket notification for NovaBlend Console — predicate device identification, bench testing per recognized standards, software documentation per FDA guidance and eCopy submission.
NovaBlend ConsoleMicroProbe Flex
Health Canada MDL — Class IIPlanned
Medical Device Licence — Canadian Medical Devices Regulations (SOR/98-282)
VELVALIZE application: Medical Device Licence application for the Canadian market — Class II active device classification, MDSAP audit (ISO 13485 integrated), bilingual labeling and mandatory incident reporting to Health Canada.
Disclaimer: VELVALIZE products are currently in the R&D and pre-certification phase. The standards and certifications listed represent the regulatory targets for market authorization. Formal certification audits, clinical evaluations and regulatory submissions have not yet been completed.
