Cleared Traditional

K872711 - MODEL 20-C W/AR-10A/U ATTACH. FOR ARTHR...

K872711 is an FDA 510(k) clearance for MODEL 20-C W/AR-10A/U ATTACH. FOR ARTHR..., 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 83-day FDA review.

K872711 · Directed Energy, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 1987
Decision
83d
Days
Class 2
Risk

K872711 is an FDA 510(k) clearance for the MODEL 20-C W/AR-10A/U ATTACH. FOR ARTHRO. 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 September 28, 1987 after a review of 83 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 - K872711

510(k) Number K872711 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 07, 1987
Decision Date September 28, 1987
Days to Decision 83 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
32d faster than avg
Panel avg: 115d · This submission: 83d
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 K872711.
MODEL 5001 MICROMANIPULATOR FOR USE W/TF-25 CO2
K873246 · Coherent Medical Group · Nov 1987
COHERENT XA-30 CO2 SURGICAL LASER
K873963 · Coherent Medical Group · Oct 1987
CODMAN NEUROLASE LASER SYSTEM
K872179 · Codman & Shurtleff, Inc. · Oct 1987
LPM-1 (LASER POWER METER)
K871619 · Bio-Tek Instruments, Inc. · Jul 1987
MODEL 20-C W/SA-20A/U OPTICAL ATTACHMENT/SURG USE
K870837 · Directed Energy, Inc. · May 1987
MODEL 10-C W/ SA-10A/U OPTICAL ATTACHMENT/SURG USE
K870838 · Directed Energy, Inc. · May 1987