Cleared Traditional

K931499 - Q-11 OPHTHALMIC LASER

K931499 is an FDA 510(k) clearance for Q-11 OPHTHALMIC LASER, manufactured by Hgm, Inc.. The device is a Class 2 General & Plastic Surgery device with product code GEX cleared through the Traditional 510(k) pathway after a 147-day FDA review.

K931499 · Hgm, Inc. · General & Plastic Surgery device
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Aug 1993
Decision
147d
Days
Class 2
Risk

K931499 is an FDA 510(k) clearance for the Q-11 OPHTHALMIC 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, Inc. (Salt Lake City, US). The FDA issued a Cleared decision on August 19, 1993 after a review of 147 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, Inc. devices

FDA 510(k) Submission Details - K931499

510(k) Number K931499 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 25, 1993
Decision Date August 19, 1993
Days to Decision 147 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
32d slower than avg
Panel avg: 115d · This submission: 147d
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 1457
Devices cleared under the same product code (GEX) and FDA review panel - the closest regulatory comparables to K931499.
SHARPLASE SHORT FIBER ND:YAG DELIVERY SYSTEM
K931978 · Sharplan Lasers, Inc. · Sep 1993
NOVUS MULTIWAVELENGTH
K932468 · Coherent Medical Group · Sep 1993
ZEISS DIODE-PUMPED SOLID STATE LASER
K925642 · Carl Zeiss, Inc. · Sep 1993
SHARPLAN 2100,3000,SHARPLASER 65, 40
K920865 · Sharplan Lasers, Inc. · Aug 1993
ACCULITE(TM) OTOPROBE
K930981 · Coherent Medical Group · Jul 1993
ZEISS LASER INDIRECT OPHTHALMOSCOPE
K924588 · Carl Zeiss, Inc. · Jul 1993