Cleared Traditional

K862422 - MODEL 20-B CO2 LASER FOR GENERAL & PLAS...

K862422 is an FDA 510(k) clearance for MODEL 20-B CO2 LASER FOR GENERAL & PLAS..., 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 99-day FDA review.

K862422 · Directed Energy, Inc. · General & Plastic Surgery device
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Oct 1986
Decision
99d
Days
Class 2
Risk

K862422 is an FDA 510(k) clearance for the MODEL 20-B CO2 LASER FOR GENERAL & PLASTIC SURGERY. 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 2, 1986 after a review of 99 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 Directed Energy, Inc. devices

FDA 510(k) Submission Details - K862422

510(k) Number K862422 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 25, 1986
Decision Date October 02, 1986
Days to Decision 99 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
16d faster than avg
Panel avg: 115d · This submission: 99d
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 K862422.
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
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