Cleared Traditional

K973172 - RESPOSABLE BARE FIBERS

K973172 is an FDA 510(k) clearance for RESPOSABLE BARE FIBERS, 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 162-day FDA review.

K973172 · Trimedyne, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 1998
Decision
162d
Days
Class 2
Risk

K973172 is an FDA 510(k) clearance for the RESPOSABLE BARE FIBERS. 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. (Irvine, US). The FDA issued a Cleared decision on February 3, 1998 after a review of 162 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General & Plastic Surgery review framework, consistent with the majority of Class II 510(k) submissions.

View all Trimedyne, Inc. devices

FDA 510(k) Submission Details - K973172

510(k) Number K973172 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 25, 1997
Decision Date February 03, 1998
Days to Decision 162 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
47d slower than avg
Panel avg: 115d · This submission: 162d
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 K973172.
CYNOSURE PHOTOGENICA 532 LASER
K974900 · Cynosure, Inc. · Feb 1998
SLT SELECT FIBER DELIVERY SYSTEM AND CONTACT TIPS
K980156 · Surgical Laser Technologies, Inc. · Feb 1998
CANDELA GENTLELASE GL DERMATOLOGICAL LASER
K974381 · Candela Corp. · Feb 1998
PRIMA KTP LASER SYSTEM
K973828 · Nidek, Inc. · Jan 1998
TEMPERATURE DIAGNOSTIC ACCESSORY
K973764 · New Star Lasers, Inc. · Dec 1997
COHERENT POPEYE OPHTHALMIC LASER SYSTEM, COHERENT POPEYE OPHTHALMIC LASER SYSTEM IN COMBINATION WITH THE COHERENT ARGONS
K973470 · Lumenis, Inc. · Dec 1997