Cleared Traditional

K922634 - SLT LASER DELIVERY SYSTEM

K922634 is an FDA 510(k) clearance for SLT LASER DELIVERY SYSTEM, 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 50-day FDA review.

K922634 · Surgical Laser Technologies, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 1992
Decision
50d
Days
Class 2
Risk

K922634 is an FDA 510(k) clearance for the SLT LASER DELIVERY 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 Surgical Laser Technologies, Inc. (Oaks, US). The FDA issued a Cleared decision on July 15, 1992 after a review of 50 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 Surgical Laser Technologies, Inc. devices

FDA 510(k) Submission Details - K922634

510(k) Number K922634 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 26, 1992
Decision Date July 15, 1992
Days to Decision 50 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
65d faster than avg
Panel avg: 115d · This submission: 50d
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 K922634.
LASERSCOPE'S MICROSPOT DERMASTAT
K914918 · Laserscope · Jul 1992
COHERENT VERSAPULSE(TM) 2.1XE/2.1L HOLMI SURG LASE
K914136 · Coherent Medical Group · Jul 1992
CYNOSURE PHOTOTRIPTER LASER
K921840 · Cynosure, Inc. · Jul 1992
ZEISS MULTI YAG LASER
K920967 · Carl Zeiss, Inc. · Jul 1992
CYNOSURE PHOTGENICA V CUTANEOUS VAS. LESION LASER
K921842 · Cynosure, Inc. · Jul 1992
EXCEL DUOPULSE MODEL 3000 COMBINATION HO/ER:YAG
K922375 · Excel Tech. , Ltd. · Jul 1992