Cleared Traditional

K864563 - MODEL LS 840

K864563 is an FDA 510(k) clearance for MODEL LS 840, 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 141-day FDA review.

K864563 · Cooper Lasersonics, Inc. · General & Plastic Surgery device
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Optimized for regulatory review, auditing and printing
Apr 1987
Decision
141d
Days
Class 2
Risk

K864563 is an FDA 510(k) clearance for the MODEL LS 840, CO2 LASER. 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 9, 1987 after a review of 141 days - within the typical 510(k) review window.

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 Cooper Lasersonics, Inc. devices

FDA 510(k) Submission Details - K864563

510(k) Number K864563 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received November 19, 1986
Decision Date April 09, 1987
Days to Decision 141 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
26d slower than avg
Panel avg: 115d · This submission: 141d
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 K864563.
MODEL 10-C WITH AN SA-10B/U OPTICAL ATTACHMENT
K870970 · Directed Energy, Inc. · May 1987
MODEL 20-C WITH AN SA-20B/U OPTICAL ATTACHMENT
K870971 · Directed Energy, Inc. · May 1987
MODEL LS 860, CO2 LASER
K864562 · Cooper Lasersonics, Inc. · Apr 1987
OMNIPLUS FREQ DOUBLE ND:YAG PHOTOSURG SYS/NEURO
K862514 · Laserscope · Feb 1987
SAPPHIRE LASER BLADES (LASER BLADES) ND: YAG
K863086 · Cooper Lasersonics, Inc. · Dec 1986
CANDELA MODEL SPT-1, PULSED DYE LASER
K861179 · Candela Corp. · Nov 1986