Cleared Traditional

K904700 - ENDOCOAGULATOR KRS568(TM) LASER

K904700 is an FDA 510(k) clearance for ENDOCOAGULATOR KRS568(TM) LASER, manufactured by Hgm Medical Laser 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 126-day FDA review.

K904700 · Hgm Medical Laser Systems, Inc. · General & Plastic Surgery device
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Optimized for regulatory review, auditing and printing
Feb 1991
Decision
126d
Days
Class 2
Risk

K904700 is an FDA 510(k) clearance for the ENDOCOAGULATOR KRS568(TM) 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 Hgm Medical Laser Systems, Inc. (Salt Lake City, US). The FDA issued a Cleared decision on February 19, 1991 after a review of 126 days - within the typical 510(k) review window.

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 Hgm Medical Laser Systems, Inc. devices

FDA 510(k) Submission Details - K904700

510(k) Number K904700 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 16, 1990
Decision Date February 19, 1991
Days to Decision 126 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
11d slower than avg
Panel avg: 115d · This submission: 126d
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 K904700.
SURGICAL CARBON DIOXIDE LASER SYST MODEL 20-CH
K904930 · Directed Energy, Inc. · Mar 1991
OPTILASE (TM) MODEL 900 ARGON
K903838 · Trimedyne, Inc. · Mar 1991
KTP DISC KIT
K905424 · Laserscope · Mar 1991
ALTAIR
K905072 · Pfizer Laser Systems · Feb 1991
NIDEK DC-3000 DIODE LASER PHOTOCOAGULATOR
K903639 · Nidek, Inc. · Feb 1991
PEGASUS WITH ACCESSORIES
K905082 · Pfizer Laser Systems · Jan 1991