Cleared Traditional

K921300 - MODEL PC ARGON ION LASER

K921300 is an FDA 510(k) clearance for MODEL PC ARGON ION 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 202-day FDA review.

K921300 · Hgm Medical Laser Systems, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 1992
Decision
202d
Days
Class 2
Risk

K921300 is an FDA 510(k) clearance for the MODEL PC ARGON ION 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 October 6, 1992 after a review of 202 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 - K921300

510(k) Number K921300 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 18, 1992
Decision Date October 06, 1992
Days to Decision 202 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
87d slower than avg
Panel avg: 115d · This submission: 202d
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 K921300.
ALCON(R) FX2(TM) PHOTOCOAGULATOR
K914334 · Alcon Laboratories · Nov 1992
ZEISS VISULAS ARGON LASER
K923341 · Carl Zeiss, Inc. · Oct 1992
CYNOSURE PHOTOGENICA T TATTOO REMOVAL LASER
K923683 · Cynosure, Inc. · Oct 1992
KTP/532 & KTP/YAG
K913990 · Laserscope · Sep 1992
CYNOSURE PHOTODENT, INTRAORAL SURGICAL LASER
K921843 · Cynosure, Inc. · Aug 1992
CYNOSURE PHOTOGENICA P PIGMENTED LESION LASER
K921841 · Cynosure, Inc. · Aug 1992