Cleared Traditional

K952554 - SCHWARTZ ELECTRO-OPTICS, INC. TRILASE LASER SYSTEM

K952554 is an FDA 510(k) clearance for SCHWARTZ ELECTRO-OPTICS, manufactured by Schwartz Electro-Optics, Inc.. The device is a Class 2 General & Plastic Surgery device with product code GEX cleared through the Traditional 510(k) pathway after a 87-day FDA review.

K952554 · Schwartz Electro-Optics, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 1995
Decision
87d
Days
Class 2
Risk

K952554 is an FDA 510(k) clearance for the SCHWARTZ ELECTRO-OPTICS, INC. TRILASE 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 Schwartz Electro-Optics, Inc. (Orlando, US). The FDA issued a Cleared decision on August 28, 1995 after a review of 87 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 Schwartz Electro-Optics, Inc. devices

FDA 510(k) Submission Details - K952554

510(k) Number K952554 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 02, 1995
Decision Date August 28, 1995
Days to Decision 87 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
28d faster than avg
Panel avg: 115d · This submission: 87d
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 1884
Devices cleared under the same product code (GEX) and FDA review panel - the closest regulatory comparables to K952554.
SLT THERMALITE DIODE LASER SERIES, DIODE 980, 810, 940
K952661 · Surgical Laser Technologies, Inc. · Oct 1995
POWERSCULPTOR PROBES
K952755 · Cardiogenes · Sep 1995
TAPERTIP MULTISUE HOLMIUM ARTHROSCOPIC HANDPIECE, VARIOUS ENDFIRING MODELS, WITH/OUT A STERILIZABLE INSTRUMENT TRAY
K953494 · Trimedyne, Inc. · Sep 1995
MODIFIED LUXAR LX-20 FAMILY CO2 LASER SYSTEM
K953074 · Luxar Corp. · Aug 1995
CORSSFIRE PLUS
K953658 · Cardiogenes · Aug 1995
SLT MULTIDIMENSIONAL CONTACT LASER SYSTEM & WCE DIFFUSER FLAT PROBE DF 2
K952216 · Surgical Laser Technologies, Inc. · Aug 1995