Cleared Traditional

K850779 - MODEL 4000 ND:YAG LASER FOR GENITOURINA...

K850779 is an FDA 510(k) clearance for MODEL 4000 ND:YAG LASER FOR GENITOURINA..., manufactured by Cooper Lasersonics, Inc.. The device is a Class 2 General & Plastic Surgery device with product code GEX cleared through the Traditional 510(k) pathway after a 35-day FDA review.

K850779 · Cooper Lasersonics, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 1985
Decision
35d
Days
Class 2
Risk

K850779 is an FDA 510(k) clearance for the MODEL 4000 ND:YAG LASER FOR GENITOURINARY APPLICAT. 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 Cooper Lasersonics, Inc. (Santa Clara, US). The FDA issued a Cleared decision on April 2, 1985 after a review of 35 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 Cooper Lasersonics, Inc. devices

FDA 510(k) Submission Details - K850779

510(k) Number K850779 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 26, 1985
Decision Date April 02, 1985
Days to Decision 35 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
80d faster than avg
Panel avg: 115d · This submission: 35d
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 1458
Devices cleared under the same product code (GEX) and FDA review panel - the closest regulatory comparables to K850779.
MINI-HALO CO2 LASER SYSTEM
K843915 · CooperVision, Inc. · May 1985
S.L.T. LASER DELIVERY HANDLES W/SURGICAL RODS
K844643 · Surgical Laser Technologies, Inc. · May 1985
SURGICAL LASER MICRO-TIPS
K844644 · Surgical Laser Technologies, Inc. · May 1985
ND-YAG LASER 8000 NEUROSURGERY APPLICA
K842703 · Cooper Lasersonics, Inc. · Oct 1984
BARD CO2 SURGICAL LASER SYS SLS-50/100
K834166 · C.R. Bard, Inc. · Sep 1984
HALO CO LASER SYSTEM
K841234 · Directed Energy, Inc. · Jul 1984