Cleared Traditional

ILLUMINA MODEL 25 CO2 LASER FOR GENERAL/PLASTIC SU

K880807 · Cooper Lasersonics, Inc. · General & Plastic Surgery

Apr 1988

Decision

52d

Days

Class 2

Risk

About This 510(k) Submission

K880807 is an FDA 510(k) clearance for the ILLUMINA MODEL 25 CO2 LASER FOR GENERAL/PLASTIC SU, a Powered Laser Surgical Instrument (Class II — Special Controls, product code GEX), submitted by Cooper Lasersonics, Inc. (Santa Clara, US). The FDA issued a Cleared decision on April 18, 1988, 52 days after receiving the submission on February 26, 1988. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4810.

Submission Details

510(k) Number	K880807 FDA.gov
FDA Decision	Cleared SESE
Date Received	February 26, 1988
Decision Date	April 18, 1988
Days to Decision	52 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.