Cleared Traditional

ILLUMINA 25 CO2 LASER SYSTEM

K880428 · Cooper Lasersonics, Inc. · Ear, Nose, Throat
Apr 1988
Decision
77d
Days
Class 2
Risk

About This 510(k) Submission

K880428 is an FDA 510(k) clearance for the ILLUMINA 25 CO2 LASER SYSTEM, a Laser, Ent Microsurgical Carbon-dioxide (Class II — Special Controls, product code EWG), submitted by Cooper Lasersonics, Inc. (Santa Clara, US). The FDA issued a Cleared decision on April 18, 1988, 77 days after receiving the submission on February 1, 1988. This device falls under the Ear, Nose, Throat review panel. Regulated under 21 CFR 874.4500.

Submission Details

510(k) Number K880428 FDA.gov
FDA Decision Cleared SESE
Date Received February 01, 1988
Decision Date April 18, 1988
Days to Decision 77 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
Summary —

Device Classification

Product Code EWG — Laser, Ent Microsurgical Carbon-dioxide
Device Class Class II — Special Controls
CFR Regulation 21 CFR 874.4500

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