Cleared Traditional

K910272 - HGM COMBINATION ND:YAG & SOLID STATE GREEN

K910272 is an FDA 510(k) clearance for HGM COMBINATION ND:YAG & SOLID STATE GREEN, 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 198-day FDA review.

K910272 · Hgm Medical Laser Systems, Inc. · General & Plastic Surgery device
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Aug 1991
Decision
198d
Days
Class 2
Risk

K910272 is an FDA 510(k) clearance for the HGM COMBINATION ND:YAG & SOLID STATE GREEN. 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 August 9, 1991 after a review of 198 days - an extended review 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: 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 - K910272

510(k) Number K910272 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 23, 1991
Decision Date August 09, 1991
Days to Decision 198 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
83d slower than avg
Panel avg: 115d · This submission: 198d
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 K910272.
LASERSCOPE(R) KTP/532 AND KTP/YAG SURGICAL LASER
K911830 · Laserscope · Aug 1991
LUXUS 132 ND: YAG SURGICAL LASER SYSTEM
K911987 · Heraeus Lasersonics, Inc. · Aug 1991
ULTRAPULSE(TM) CARBON DIOXIDE SURGICAL LASER
K912029 · Coherent Medical Group · Aug 1991
CENTAURI/PEGASUS
K905802 · Pfizer Laser Systems · Jul 1991
CENTAURI YAG LASER SYST, GYNECOLOGY
K904632 · Pfizer Laser Systems · Jul 1991
LATERALASE TM
K903418 · Trimedyne, Inc. · Jun 1991