Cleared Traditional

LASER-35

K910200 · Endo Technic Corp. · General & Plastic Surgery

May 1991

Decision

114d

Days

Class 2

Risk

About This 510(k) Submission

K910200 is an FDA 510(k) clearance for the LASER-35, a Powered Laser Surgical Instrument (Class II — Special Controls, product code GEX), submitted by Endo Technic Corp. (Tustin, US). The FDA issued a Cleared decision on May 9, 1991, 114 days after receiving the submission on January 15, 1991. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4810.

Submission Details

510(k) Number	K910200 FDA.gov
FDA Decision	Cleared SESE
Date Received	January 15, 1991
Decision Date	May 09, 1991
Days to Decision	114 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.