Cleared Traditional

K945054 - ENDOCARE PROLASE I ADVANCED LASER DELIVERY SYSTEM

K945054 is an FDA 510(k) clearance for ENDOCARE PROLASE I ADVANCED LASER DELIV..., manufactured by Cytocare, Inc.. The device is a Class 2 General & Plastic Surgery device with product code GEX cleared through the Traditional 510(k) pathway after a 45-day FDA review.

K945054 · Cytocare, Inc. · General & Plastic Surgery device
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Nov 1994
Decision
45d
Days
Class 2
Risk

K945054 is an FDA 510(k) clearance for the ENDOCARE PROLASE I ADVANCED 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 Cytocare, Inc. (Aliso Viejo, US). The FDA issued a Cleared decision on November 28, 1994 after a review of 45 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 Cytocare, Inc. devices

FDA 510(k) Submission Details - K945054

510(k) Number K945054 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 14, 1994
Decision Date November 28, 1994
Days to Decision 45 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
70d faster than avg
Panel avg: 115d · This submission: 45d
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 2448
Devices cleared under the same product code (GEX) and FDA review panel - the closest regulatory comparables to K945054.
CANDELA Q-SWITCHED ALEXANDRITE LASER
K940173 · Candela Laser Corp. · Dec 1994
MEGABEAM LATERAL FIRE
K943527 · Ceram Optec, Inc. · Dec 1994
LATERALASE, MODIFIED
K944204 · Trimedyne, Inc. · Nov 1994
ECLIPSE 3200
K944153 · Cardiogenes · Nov 1994
MODEL 230-SAS LASER DELIVERY PROBE
K944630 · Mnlase, Inc. · Nov 1994
COAXIAL ENDOSTAT
K944977 · Laserscope · Nov 1994