Cleared Traditional

K963249 - EPILIGHT HAIR REMOVAL SYSTEM

K963249 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 322-day FDA review.

K963249 · Esc Medical Systems , Ltd. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 1997
Decision
322d
Days
Class 2
Risk

K963249 is an FDA 510(k) clearance for the EPILIGHT HAIR REMOVAL 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 July 7, 1997 after a review of 322 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 - K963249

510(k) Number K963249 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 19, 1996
Decision Date July 07, 1997
Days to Decision 322 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
207d slower than avg
Panel avg: 115d · This submission: 322d
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 1884
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