Cleared Traditional

K952661 - SLT THERMALITE DIODE LASER SERIES

K952661 is an FDA 510(k) clearance for SLT THERMALITE DIODE LASER SERIES, manufactured by Surgical Laser Technologies, Inc.. The device is a Class 2 General & Plastic Surgery device with product code GEX cleared through the Traditional 510(k) pathway after a 116-day FDA review.

K952661 · Surgical Laser Technologies, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 1995
Decision
116d
Days
Class 2
Risk

K952661 is an FDA 510(k) clearance for the SLT THERMALITE DIODE LASER SERIES, DIODE 980, 810, 940. 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 Surgical Laser Technologies, Inc. (Oaks, US). The FDA issued a Cleared decision on October 6, 1995 after a review of 116 days - within the typical 510(k) review window.

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 Surgical Laser Technologies, Inc. devices

FDA 510(k) Submission Details - K952661

510(k) Number K952661 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 12, 1995
Decision Date October 06, 1995
Days to Decision 116 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
1d slower than avg
Panel avg: 115d · This submission: 116d
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 1544
Devices cleared under the same product code (GEX) and FDA review panel - the closest regulatory comparables to K952661.
SHARPLAN LASERS, INC. SURGICAL DIODE LASER
K953794 · Sharplan Lasers, Inc. · Nov 1995
CANDELA MODEL PLTL-1 LASER SYSTEM
K953412 · Candela Laser Corp. · Oct 1995
LIHTAN 532 LASER
K951117 · Buckman Co., Inc. · Oct 1995
TAPERTIP MULTISUE HOLMIUM ARTHROSCOPIC HANDPIECE, VARIOUS ENDFIRING MODELS, WITH/OUT A STERILIZABLE INSTRUMENT TRAY
K953494 · Trimedyne, Inc. · Sep 1995
SLT MULTIDIMENSIONAL CONTACT LASER SYSTEM & WCE DIFFUSER FLAT PROBE DF 2
K952216 · Surgical Laser Technologies, Inc. · Aug 1995
CYNOSURE PHOTOGENICA T10 TATTOO REMOVAL LASER
K950684 · Cynosure, Inc. · Aug 1995