Cleared Traditional

K880428 - ILLUMINA 25 CO2 LASER SYSTEM

K880428 is an FDA 510(k) clearance for ILLUMINA 25 CO2 LASER SYSTEM, manufactured by Cooper Lasersonics, Inc.. The device is a Class 2 Ear, Nose, Throat device with product code EWG cleared through the Traditional 510(k) pathway after a 77-day FDA review.

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

K880428 is an FDA 510(k) clearance for the ILLUMINA 25 CO2 LASER SYSTEM. Classified as Laser, Ent Microsurgical Carbon-dioxide (product code EWG), Class II - Special Controls.

Submitted by Cooper Lasersonics, Inc. (Santa Clara, US). The FDA issued a Cleared decision on April 18, 1988 after a review of 77 days - a notably fast clearance cycle.

This device falls under the Ear, Nose, Throat FDA review panel, regulated under 21 CFR 874.4500 - the FDA ear, nose and throat device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Cooper Lasersonics, Inc. devices

FDA 510(k) Submission Details - K880428

510(k) Number K880428 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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 -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
12d faster than avg
Panel avg: 89d · This submission: 77d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

EWG Device Classification - Class 2, Special Controls

Product Code EWG Laser, Ent Microsurgical Carbon-dioxide
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 874.4500
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Ear, Nose, Throat devices follow this clearance model.

Regulatory Peers - EWG Laser, Ent Microsurgical Carbon-dioxide

All 13
Devices cleared under the same product code (EWG) and FDA review panel - the closest regulatory comparables to K880428.
ILLUMINA 40 CO2 LASER SYSTEM
K880427 · Cooper Lasersonics, Inc. · Apr 1988
ILLUMINA 55 CO2 LASER SYSTEM
K880429 · Cooper Lasersonics, Inc. · Apr 1988
MODEL 20-B W/OB-10A/U ATTACH. FOR EAR, NOSE/THROAT
K872710 · Directed Energy, Inc. · Sep 1987
MODEL 20-C W/BR-20A/U ATTACH/MODEL HL-3.O ATTACH
K870840 · Directed Energy, Inc. · Jun 1987
LASERSCOPE OMNIPLUS PHOTOSURGICAL SYSTEM FOR (ENT)
K864975 · Laserscope · Feb 1987
MODEL 10-C W/LP-10A/U & OB-10A/U FOR ORAL/ENT USE
K862865 · Directed Energy, Inc. · Jan 1987