Cleared Traditional

K904342 - SERIES 1990 ARGON SURGICAL LASERS

K904342 is an FDA 510(k) clearance for SERIES 1990 ARGON SURGICAL LASERS, 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 89-day FDA review.

K904342 · Hgm Medical Laser Systems, Inc. · General & Plastic Surgery device
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Dec 1990
Decision
89d
Days
Class 2
Risk

K904342 is an FDA 510(k) clearance for the SERIES 1990 ARGON SURGICAL LASERS, E1,E6,E14&E20A. 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 December 19, 1990 after a review of 89 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 Hgm Medical Laser Systems, Inc. devices

FDA 510(k) Submission Details - K904342

510(k) Number K904342 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 21, 1990
Decision Date December 19, 1990
Days to Decision 89 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
26d faster than avg
Panel avg: 115d · This submission: 89d
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 K904342.
CENTAURI YAG LASER SYST, EAR, NOSE , THROAT
K904627 · Pfizer Laser Systems · Jan 1991
CENTAURI YAG LASER SYST, GASTROENTEROLOGY
K904628 · Pfizer Laser Systems · Jan 1991
CENTAURI YAG LASER SYST, UROLOGY
K904629 · Pfizer Laser Systems · Jan 1991
HERCULES MODEL 5000 AND 5040 ND:YAG LASER SYSTEMS
K904610 · Heraeus Lasersonics, Inc. · Dec 1990
CENTAURI YAG LASER SYST, OPHTHAMOLOGY
K904630 · Pfizer Laser Systems · Dec 1990
CO2 LASERS AND INFRAGUIDE DELIVERY SYSTEM
K904423 · Heraeus Lasersonics, Inc. · Dec 1990