Cleared Traditional

K943479 - GENEMED YAG 1000 MEDICAL LASER

K943479 is an FDA 510(k) clearance for GENEMED YAG 1000 MEDICAL LASER, manufactured by Genemed, Inc.. The device is a Class 2 General & Plastic Surgery device with product code GEX cleared through the Traditional 510(k) pathway after a 72-day FDA review.

K943479 · Genemed, Inc. · General & Plastic Surgery device
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Sep 1994
Decision
72d
Days
Class 2
Risk

K943479 is an FDA 510(k) clearance for the GENEMED YAG 1000 MEDICAL 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 Genemed, Inc. (Middlebury, US). The FDA issued a Cleared decision on September 29, 1994 after a review of 72 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 Genemed, Inc. devices

FDA 510(k) Submission Details - K943479

510(k) Number K943479 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 19, 1994
Decision Date September 29, 1994
Days to Decision 72 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
43d faster than avg
Panel avg: 115d · This submission: 72d
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 1459
Devices cleared under the same product code (GEX) and FDA review panel - the closest regulatory comparables to K943479.
COAXIAL ENDOSTAT
K944977 · Laserscope · Nov 1994
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KARL STORZ LASER ACCESSORIES
K942786 · KARL STORZ Endoscopy-America, Inc. · Sep 1994
PLTL-1 & PLDL-1 510NM PULSED DYE LASERS
K934811 · Candela Laser Corp. · Sep 1994
SLT PRISM/REFRACTING PROBE
K934208 · Surgical Laser Technologies, Inc. · Aug 1994