Cleared Traditional

K991935 - EPILIGHT HAIR REMOVAL SYSTEM, PHOTODERM HR SYSTEM

K991935 is an FDA 510(k) clearance for EPILIGHT HAIR REMOVAL SYSTEM, manufactured by Esc Medical Systems , Ltd.. The device is a Class 2 General & Plastic Surgery device with product code GEX cleared through the Traditional 510(k) pathway after a 232-day FDA review.

K991935 · Esc Medical Systems , Ltd. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 2000
Decision
232d
Days
Class 2
Risk

K991935 is an FDA 510(k) clearance for the EPILIGHT HAIR REMOVAL SYSTEM, PHOTODERM HR SYSTEM. Classified as Powered Laser Surgical Instrument within the GEX classification (a category for powered laser surgical instruments across multiple specialties), Class II - Special Controls.

Submitted by Esc Medical Systems , Ltd. (Needham, US). The FDA issued a Cleared decision on January 27, 2000 after a review of 232 days - an extended review cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4810 - the FDA general and plastic surgery device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General & Plastic Surgery review framework, consistent with the majority of Class II 510(k) submissions.

View all Esc Medical Systems , Ltd. devices

FDA 510(k) Submission Details - K991935

510(k) Number K991935 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 09, 1999
Decision Date January 27, 2000
Days to Decision 232 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
117d slower than avg
Panel avg: 115d · This submission: 232d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GEX Device Classification - Class 2, Special Controls

Product Code GEX Powered Laser Surgical Instrument
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.4810
Definition A Laser (light Amplification By Stimulated Emission Of Radiation) Based Device Having Coherence, Collimated And Typically Monochromatic Radiation. Typically Indicated To To Cut, Destroy, Remove Or Coagulate Tissue, Generally Soft Tissue, For General Surgical Purpose In Medical Specialties Of General And Plastic Surgery, Dermatology/aesthetic, Podiatry, Otolaryngology (ent), Gynecology, Neurosurgery, Orthopedics (soft Tissue), Dental And Oral Surgery, And Dentistry. The Classification Regulation 21 Cfr 878.4810 Describes A Device That Is Carbon Dioxide Or Argon Laser Intended To Cut, Destroy, Remove Or Coagulate Tissue By The Light.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most General & Plastic Surgery devices follow this clearance model.

Regulatory Peers - GEX Powered Laser Surgical Instrument

All 1883
Devices cleared under the same product code (GEX) and FDA review panel - the closest regulatory comparables to K991935.
ACME MEDICAL AESTHETIC ND:YAG LASER
K991798 · Altus Medical · Mar 2000
CERALAS D10 810NM DIODE LASER
K993828 · Ceram Optec, Inc. · Feb 2000
CERALAS D DIODE LASER SYSTEM, MODEL D15, D25,D50
K993911 · Ceram Optec, Inc. · Feb 2000
CANDELA SCLERO LONG PULSE DYE LASER
K993671 · Candela Corp. · Jan 2000
MODEL 1000 HOLMIUM LASER SYSTEM
K994273 · New Star Lasers, Inc. · Jan 2000
CYNOSURE M2 DERMATOLOGY LASER FOR HAIR REMOVAL
K994427 · Cynosure, Inc. · Jan 2000