Cleared Traditional

K873773 - ENDOCOAGULATOR MODELS 8 AND 20 ARGON LASER
(FDA 510(k) Clearance)

K873773 · Hgm, Inc. · General & Plastic Surgery

Oct 1987

Decision

27d

Days

Class 2

Risk

K873773 is an FDA 510(k) clearance for the ENDOCOAGULATOR MODELS 8 AND 20 ARGON LASER, a Powered Laser Surgical Instrument (Class II — Special Controls, product code GEX), submitted by Hgm, Inc. (Salt Lake City, US). The FDA issued a Cleared decision on October 13, 1987, 27 days after receiving the submission on September 16, 1987. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4810.

Submission Details

510(k) Number	K873773 FDA.gov
FDA Decision	Cleared SESE
Date Received	September 16, 1987
Decision Date	October 13, 1987
Days to Decision	27 days
Submission Type	Traditional
Review Panel	General & Plastic Surgery (SU)
Summary	—

Device Classification

Product Code	GEX — Powered Laser Surgical Instrument
Device Class	Class II — 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.