Cleared Traditional

K862862 - MODEL 10-C W/FL-10A/U FOR SURGERY AND D...

K862862 is an FDA 510(k) clearance for MODEL 10-C W/FL-10A/U FOR SURGERY AND D..., manufactured by Directed Energy, Inc.. The device is a Class 2 General & Plastic Surgery device with product code GEX cleared through the Traditional 510(k) pathway after a 52-day FDA review.

K862862 · Directed Energy, Inc. · General & Plastic Surgery device
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Optimized for regulatory review, auditing and printing
Sep 1986
Decision
52d
Days
Class 2
Risk

K862862 is an FDA 510(k) clearance for the MODEL 10-C W/FL-10A/U FOR SURGERY AND DERMATOLOGY. 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 Directed Energy, Inc. (Los Angeles, US). The FDA issued a Cleared decision on September 19, 1986 after a review of 52 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 Directed Energy, Inc. devices

FDA 510(k) Submission Details - K862862

510(k) Number K862862 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 29, 1986
Decision Date September 19, 1986
Days to Decision 52 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
63d faster than avg
Panel avg: 115d · This submission: 52d
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 1536
Devices cleared under the same product code (GEX) and FDA review panel - the closest regulatory comparables to K862862.
ND:YAG LASER, MODEL 6000 FOR NEUROSURGERY
K863183 · Cooper Lasersonics, Inc. · Oct 1986
MODEL LS-870 CO2 SURGICAL LASER SYSTEM (MODIFIED)
K860831 · Cooper Lasersonics, Inc. · Oct 1986
MODEL 20-B CO2 LASER FOR GENERAL & PLASTIC SURGERY
K862422 · Directed Energy, Inc. · Oct 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
COOPER LASER SONICS ND: YAG LASER, MODEL 8008
K853117 · Cooper Lasersonics, Inc. · Aug 1986