Cleared Traditional

LQ1106 OPHTHALMIC YAG LASER

K882772 · Keeler Instruments, Inc. · General & Plastic Surgery

Aug 1988

Decision

51d

Days

Class 2

Risk

About This 510(k) Submission

K882772 is an FDA 510(k) clearance for the LQ1106 OPHTHALMIC YAG LASER, a Powered Laser Surgical Instrument (Class II — Special Controls, product code GEX), submitted by Keeler Instruments, Inc. (Broomall, US). The FDA issued a Cleared decision on August 26, 1988, 51 days after receiving the submission on July 6, 1988. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4810.

Submission Details

510(k) Number	K882772 FDA.gov
FDA Decision	Cleared SESE
Date Received	July 06, 1988
Decision Date	August 26, 1988
Days to Decision	51 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.