Cleared Traditional

K960867 - FREQUENCY DOUBLED ND:YAG PHOTOCOAGULATOR(VIRIDIS) FREQUENCY DOUBLED ND:YAG PHOTOCOAGULATOR(EVERGREEN 532)

K960867 is an FDA 510(k) clearance for FREQUENCY DOUBLED ND:YAG PHOTOCOAGULATO..., manufactured by B.V. Intl. S.A.. The device is a Class 2 General & Plastic Surgery device with product code GEX cleared through the Traditional 510(k) pathway after a 71-day FDA review.

K960867 · B.V. Intl. S.A. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 1996
Decision
71d
Days
Class 2
Risk

K960867 is an FDA 510(k) clearance for the FREQUENCY DOUBLED ND:YAG PHOTOCOAGULATOR(VIRIDIS) FREQUENCY DOUBLED ND:YAG PH.... 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 B.V. Intl. S.A. (Clermont-Ferrand, FR). The FDA issued a Cleared decision on May 14, 1996 after a review of 71 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 B.V. Intl. S.A. devices

FDA 510(k) Submission Details - K960867

510(k) Number K960867 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 04, 1996
Decision Date May 14, 1996
Days to Decision 71 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
44d faster than avg
Panel avg: 115d · This submission: 71d
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 2022
Devices cleared under the same product code (GEX) and FDA review panel - the closest regulatory comparables to K960867.
LASER PERIPHERALS INC. SCATTERFREE FIBER
K961079 · Laser Peripherals, LLC · May 1996
SLT FUMICH PROBE GUIDE
K960821 · Surgical Laser Technologies, Inc. · May 1996
LASER FIBER DELIVERY/CLEANING CATHETER
K960768 · Cook Urological, Inc. · May 1996
SHARPLAN LASERS, INC. SILKTOUCH XJ SCANNER
K960820 · Sharplan Lasers, Inc. · May 1996
MODIFIED LUXAR LX-20 FAMILY CO2 LASER SYSTEM
K960475 · Luxar Corp. · Apr 1996
SHARPLAN LASERS, INC. SILKTOUCH FLASH SCANNER
K960521 · Sharplan Lasers, Inc. · Apr 1996