Cleared Traditional

K853117 - COOPER LASER SONICS ND: YAG LASER

K853117 is an FDA 510(k) clearance for COOPER LASER SONICS ND: YAG LASER, 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 383-day FDA review.

K853117 · Cooper Lasersonics, Inc. · General & Plastic Surgery device
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Aug 1986
Decision
383d
Days
Class 2
Risk

K853117 is an FDA 510(k) clearance for the COOPER LASER SONICS ND: YAG LASER, MODEL 8008. 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 August 12, 1986 after a review of 383 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: Standard predicate-based submission. Elevated predicate reliance profile. 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 Cooper Lasersonics, Inc. devices

FDA 510(k) Submission Details - K853117

510(k) Number K853117 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 25, 1985
Decision Date August 12, 1986
Days to Decision 383 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
268d slower than avg
Panel avg: 115d · This submission: 383d
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 1448
Devices cleared under the same product code (GEX) and FDA review panel - the closest regulatory comparables to K853117.
MODEL 10-C W/FL-10A/U FOR SURGERY AND DERMATOLOGY
K862862 · Directed Energy, Inc. · Sep 1986
MODEL 8900 ND:YAG LASER
K863433 · Cooper Lasersonics, Inc. · Sep 1986
MODEL 8-B CO2 LASER FOR GENERAL & PLASTIC SURGERY
K862423 · Directed Energy, Inc. · Sep 1986
SURGICAL CO2 LASER SYSTEM #20/OPTICAL FOR ARTHROSC
K854998 · Directed Energy, Inc. · May 1986
SURGICAL CARBON DIOXIDE LASER SYS. #20B ULTRALIGHT
K855210 · Directed Energy, Inc. · May 1986
SHARPLAN MODEL 1020 CO2 SURGICAL LASER SYSTEM
K860087 · Sharplan Lasers, Inc. · Apr 1986