Cleared Traditional

K895363 - BIOVISION EMERALD LASER PHOTOCOAGULATOR

K895363 is an FDA 510(k) clearance for BIOVISION EMERALD LASER PHOTOCOAGULATOR, manufactured by F.I.T. of France. The device is a Class 2 General & Plastic Surgery device with product code GEX cleared through the Traditional 510(k) pathway after a 665-day FDA review.

K895363 · F.I.T. of France · General & Plastic Surgery device
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Optimized for regulatory review, auditing and printing
Jun 1991
Decision
665d
Days
Class 2
Risk

K895363 is an FDA 510(k) clearance for the BIOVISION EMERALD LASER PHOTOCOAGULATOR. 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 F.I.T. of France (Oakland, US). The FDA issued a Cleared decision on June 24, 1991 after a review of 665 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind General & Plastic Surgery submissions.

View all F.I.T. of France devices

FDA 510(k) Submission Details - K895363

510(k) Number K895363 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 28, 1989
Decision Date June 24, 1991
Days to Decision 665 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
550d slower than avg
Panel avg: 115d · This submission: 665d
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 2480
Devices cleared under the same product code (GEX) and FDA review panel - the closest regulatory comparables to K895363.
CENTAURI/PEGASUS
K905802 · Pfizer Laser Systems · Jul 1991
MODELS 5,8,20,20S ARGON ION LASERS
K912438 · Hgm Medical Laser Systems, Inc. · Jul 1991
CENTAURI YAG LASER SYST, GYNECOLOGY
K904632 · Pfizer Laser Systems · Jul 1991
LATERALASE TM
K903418 · Trimedyne, Inc. · Jun 1991
HGM ARGON ION & SOLID LIGHT LASER FOR DENTISTRY
K910602 · Hgm Medical Laser Systems, Inc. · Jun 1991
CENTAURI YAG LASER SYST, NEUROSURGERY
K904631 · Pfizer Laser Systems · Jun 1991