Cleared Traditional

K895663 - SITE 810E PHOTOCOAGULATOR AND ACCESSORIES

K895663 is the FDA 510(k) clearance for SITE 810E PHOTOCOAGULATOR AND ACCESSORIES by Site Microsurgical Systems, Inc.. It is a Class 2 General & Plastic Surgery device (product code GEX) cleared through the Traditional 510(k) pathway after a 75-day FDA review.

K895663 · Site Microsurgical Systems, Inc. · General & Plastic Surgery device
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Dec 1989
Decision
75d
Days
Class 2
Risk

K895663 is an FDA 510(k) clearance for the SITE 810E PHOTOCOAGULATOR AND ACCESSORIES. 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 Site Microsurgical Systems, Inc. (Horsham, US). The FDA issued a Cleared decision on December 4, 1989 after a review of 75 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 Site Microsurgical Systems, Inc. devices

Submission Details

510(k) Number K895663 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 20, 1989
Decision Date December 04, 1989
Days to Decision 75 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
40d faster than avg
Panel avg: 115d · This submission: 75d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 1171
Devices cleared under the same product code (GEX) and FDA review panel - the closest regulatory comparables to K895663.
GYN-PROBE
K895774 · Trimedyne, Inc. · Jan 1990
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K895430 · Heraeus Lasersonics, Inc. · Nov 1989
ILLUMINA MODEL 25, 40 AND 55 CO2 LASER SYSTEMS
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