Cleared Traditional

K897157 - OPTILASE YAG MODEL 1000 ACV SURGICAL LA...

K897157 is an FDA 510(k) clearance for OPTILASE YAG MODEL 1000 ACV SURGICAL LA..., manufactured by Trimedyne, Inc.. The device is a Class 2 General & Plastic Surgery device with product code GEX cleared through the Traditional 510(k) pathway after a 58-day FDA review.

K897157 · Trimedyne, Inc. · General & Plastic Surgery device
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Optimized for regulatory review, auditing and printing
Feb 1990
Decision
58d
Days
Class 2
Risk

K897157 is an FDA 510(k) clearance for the OPTILASE YAG MODEL 1000 ACV SURGICAL LASER SYSTEM. Classified as Powered Laser Surgical Instrument within the GEX classification (a category for powered laser surgical instruments across multiple specialties), Class II - Special Controls.

Submitted by Trimedyne, Inc. (Tustin, US). The FDA issued a Cleared decision on February 22, 1990 after a review of 58 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4810 - the FDA general and plastic surgery 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 Trimedyne, Inc. devices

FDA 510(k) Submission Details - K897157

510(k) Number K897157 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 26, 1989
Decision Date February 22, 1990
Days to Decision 58 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
57d faster than avg
Panel avg: 115d · This submission: 58d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GEX Device Classification - Class 2, Special Controls

Product Code GEX Powered Laser Surgical Instrument
Device Class Class 2 - 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.
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 General & Plastic Surgery devices follow this clearance model.

Regulatory Peers - GEX Powered Laser Surgical Instrument

All 1566
Devices cleared under the same product code (GEX) and FDA review panel - the closest regulatory comparables to K897157.
NIDEK, INC. BIO-DC LASER DELIVERY SYSTEM
K900165 · Nidek, Inc. · Mar 1990
SHARPLAN ND:YAG DISPOSABLE FIBER DELIVERY SYSTEM
K900153 · Sharplan Lasers, Inc. · Mar 1990
SHARPLAN 1041 SEALED-OFF CO2 SURGICAL LASER SYSTEM
K900077 · Sharplan Lasers, Inc. · Mar 1990
SHARPLAN ND:YAG LASER FOR ARTHROSCOPY/MENISCECTOMY
K896762 · Sharplan Lasers, Inc. · Feb 1990
BISTAT ELECTROSURGICAL UNIT 60-5400-001
K896838 · Aspen Laboratories, Inc. · Feb 1990
ILLUMINA MODELS 30, 40 & 55 CO2, MILLIWATT POWER
K896517 · Heraeus Lasersonics, Inc. · Feb 1990