Cleared Traditional

K960821 - SLT FUMICH PROBE GUIDE

K960821 is an FDA 510(k) clearance for SLT FUMICH PROBE GUIDE, 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 77-day FDA review.

K960821 · Surgical Laser Technologies, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 1996
Decision
77d
Days
Class 2
Risk

K960821 is an FDA 510(k) clearance for the SLT FUMICH PROBE GUIDE. 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 May 16, 1996 after a review of 77 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 - K960821

510(k) Number K960821 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 29, 1996
Decision Date May 16, 1996
Days to Decision 77 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
38d faster than avg
Panel avg: 115d · This submission: 77d
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 K960821.
SHARPLAN LASERS, INC. AF ACUSPOT MICROMANIPULATOR (713)
K962974 · Sharplan Lasers, Inc. · Aug 1996
SHARPLAN LASERS, INC. RUBY LASER SYSTEM
K961279 · Sharplan Lasers, Inc. · Jun 1996
CANDELA Q-SWITCHED ALEXANDRITE LASERS
K955662 · Candela Laser Corp. · Jun 1996
LASER FIBER DELIVERY/CLEANING CATHETER
K960768 · Cook Urological, Inc. · May 1996
SHARPLAN LASERS, INC. SILKTOUCH XJ SCANNER
K960820 · Sharplan Lasers, Inc. · May 1996
SHARPLAN LASERS, INC. SILKTOUCH FLASH SCANNER
K960521 · Sharplan Lasers, Inc. · Apr 1996