Cleared Traditional

ACCESSORIES FOR SYS. 400 CO2 SURG. LASER

K791895 · Coherent Medical Division · General & Plastic Surgery

Dec 1979

Decision

86d

Days

Class 2

Risk

About This 510(k) Submission

K791895 is an FDA 510(k) clearance for the ACCESSORIES FOR SYS. 400 CO2 SURG. LASER, a Powered Laser Surgical Instrument (Class II — Special Controls, product code GEX), submitted by Coherent Medical Division (Mchenry, US). The FDA issued a Cleared decision on December 20, 1979, 86 days after receiving the submission on September 25, 1979. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4810.

Submission Details

510(k) Number	K791895 FDA.gov
FDA Decision	Cleared SESE
Date Received	September 25, 1979
Decision Date	December 20, 1979
Days to Decision	86 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.