Cleared Traditional

K982827 - DERMA K ER:YAG/CO2 LASER

K982827 is an FDA 510(k) clearance for DERMA K ER:YAG/CO2 LASER, manufactured by Esc Medical Systems, Inc.. The device is a Class 2 General & Plastic Surgery device with product code GEX cleared through the Traditional 510(k) pathway after a 34-day FDA review.

K982827 · Esc Medical Systems, Inc. · General & Plastic Surgery device
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Optimized for regulatory review, auditing and printing
Sep 1998
Decision
34d
Days
Class 2
Risk

K982827 is an FDA 510(k) clearance for the DERMA K ER:YAG/CO2 LASER. 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, Inc. (Needham, US). The FDA issued a Cleared decision on September 14, 1998 after a review of 34 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Esc Medical Systems, Inc. devices

FDA 510(k) Submission Details - K982827

510(k) Number K982827 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 11, 1998
Decision Date September 14, 1998
Days to Decision 34 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
81d faster than avg
Panel avg: 115d · This submission: 34d
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 K982827.
KAPLAN PENDULASER 115 SURGICAL LASER WITH OPTOSCAN II
K980398 · Optomedic Medical Technologies , Ltd. · Sep 1998
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K981143 · Exmoor Plastics , Ltd. · Sep 1998
DORNIER MEDILAS D
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CYNOSURE CO3 ER:YAG LASER
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OCULIGHT GL WITH THE DERMATOLOGY HANDPIECE
K982031 · Iridex Corp · Sep 1998
COMBINATION ND:YAG AND FREQUENCY DOUBLED SOLID STATE GREEN LASER
K981952 · Instruments For Medicine and Diagnostics · Sep 1998