Cleared Traditional

K862863 - MODEL 10-C W/LC-10A/U FOR OPHTHALMIC & ...

K862863 is an FDA 510(k) clearance for MODEL 10-C W/LC-10A/U FOR OPHTHALMIC & ..., 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 87-day FDA review.

K862863 · Directed Energy, Inc. · General & Plastic Surgery device
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Oct 1986
Decision
87d
Days
Class 2
Risk

K862863 is an FDA 510(k) clearance for the MODEL 10-C W/LC-10A/U FOR OPHTHALMIC & ORBITAL USE. 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 October 24, 1986 after a review of 87 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 - K862863

510(k) Number K862863 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 29, 1986
Decision Date October 24, 1986
Days to Decision 87 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
28d faster than avg
Panel avg: 115d · This submission: 87d
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 K862863.
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
MODEL 8-B CO2 LASER FOR OPTHALMIC & ORBITAL SURG
K862408 · Directed Energy, Inc. · Oct 1986
MODEL 20-C W/FL-20A/U FOR SURGERY & DERMATOLOGY
K862864 · Directed Energy, Inc. · Oct 1986
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