Cleared Traditional

CONBIO-MEDLITE Q-SWITCHED ND:YAG LASER SYSTEM

K922935 · Buckman Co., Inc. · General & Plastic Surgery

Apr 1993

Decision

293d

Days

Class 2

Risk

About This 510(k) Submission

K922935 is an FDA 510(k) clearance for the CONBIO-MEDLITE Q-SWITCHED ND:YAG LASER SYSTEM, a Powered Laser Surgical Instrument (Class II — Special Controls, product code GEX), submitted by Buckman Co., Inc. (Concord, US). The FDA issued a Cleared decision on April 7, 1993, 293 days after receiving the submission on June 18, 1992. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4810.

Submission Details

510(k) Number	K922935 FDA.gov
FDA Decision	Cleared SESE
Date Received	June 18, 1992
Decision Date	April 07, 1993
Days to Decision	293 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.