Cleared Traditional

K931305 - ECLIPSE 3200 FOR USE IN UROLOGY APPLICATIONS

K931305 is an FDA 510(k) clearance for ECLIPSE 3200 FOR USE IN UROLOGY APPLICA..., manufactured by Cardiogenes. The device is a Class 2 General & Plastic Surgery device with product code GEX cleared through the Traditional 510(k) pathway after a 298-day FDA review.

K931305 · Cardiogenes · General & Plastic Surgery device
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Jan 1994
Decision
298d
Days
Class 2
Risk

K931305 is an FDA 510(k) clearance for the ECLIPSE 3200 FOR USE IN UROLOGY APPLICATIONS. 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 Cardiogenes (Palo Alto, US). The FDA issued a Cleared decision on January 7, 1994 after a review of 298 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General & Plastic Surgery review framework, consistent with the majority of Class II 510(k) submissions.

View all Cardiogenes devices

FDA 510(k) Submission Details - K931305

510(k) Number K931305 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 15, 1993
Decision Date January 07, 1994
Days to Decision 298 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
183d slower than avg
Panel avg: 115d · This submission: 298d
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 2648
Devices cleared under the same product code (GEX) and FDA review panel - the closest regulatory comparables to K931305.
UROTEK LASER CATHETER
K934389 · Energy Life Systems Corp. · Feb 1994
HYBRID SURGICAL DEVICE MODIFICATION
K935258 · Lca, Inc. · Jan 1994
SLASE 210 & SLASE 210 PLUS HOLMIUM LASER SYSTEMS
K933007 · Sunrise Technologies, Inc. · Jan 1994
MEGABEAM LATERAL FIRE FIBER OPTIC DELIVERY SYST
K934008 · Ceram Optec, Inc. · Jan 1994
MEDICAL LASER MIXTURE
K935310 · Acetylene Gas Co. · Dec 1993
ZEISS OPMILAS 144 SURGICAL LASERS
K932376 · Carl Zeiss, Inc. · Dec 1993