Cleared Traditional

ZEISS VISULAS ARGON LASER

K923341 · Carl Zeiss, Inc. · General & Plastic Surgery

Oct 1992

Decision

145d

Days

Class 2

Risk

About This 510(k) Submission

K923341 is an FDA 510(k) clearance for the ZEISS VISULAS ARGON LASER, a Powered Laser Surgical Instrument (Class II — Special Controls, product code GEX), submitted by Carl Zeiss, Inc. (Princeton, US). The FDA issued a Cleared decision on October 28, 1992, 145 days after receiving the submission on June 5, 1992. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4810.

Submission Details

510(k) Number	K923341 FDA.gov
FDA Decision	Cleared SESE
Date Received	June 05, 1992
Decision Date	October 28, 1992
Days to Decision	145 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.