Cleared Traditional

OPHTHALAS 532 SOLID STATE PHOTOCOAGULATOR

K932062 · Alcon Laboratories · General & Plastic Surgery

Mar 1994

Decision

323d

Days

Class 2

Risk

About This 510(k) Submission

K932062 is an FDA 510(k) clearance for the OPHTHALAS 532 SOLID STATE PHOTOCOAGULATOR, a Powered Laser Surgical Instrument (Class II — Special Controls, product code GEX), submitted by Alcon Laboratories (Fort Worth, US). The FDA issued a Cleared decision on March 18, 1994, 323 days after receiving the submission on April 29, 1993. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4810.

Submission Details

510(k) Number	K932062 FDA.gov
FDA Decision	Cleared SESE
Date Received	April 29, 1993
Decision Date	March 18, 1994
Days to Decision	323 days
Submission Type	Traditional
Review Panel	General & Plastic Surgery (SU)
Summary	Statement

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.