Cleared Traditional

K894241 - MODEL 20-CH W/ AR-10A/U OPTICAL ATTACHMENT

K894241 is an FDA 510(k) clearance for MODEL 20-CH W/ AR-10A/U OPTICAL ATTACHMENT, 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 362-day FDA review.

K894241 · Directed Energy, Inc. · General & Plastic Surgery device
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Jun 1990
Decision
362d
Days
Class 2
Risk

K894241 is an FDA 510(k) clearance for the MODEL 20-CH W/ AR-10A/U OPTICAL ATTACHMENT. 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 June 18, 1990 after a review of 362 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 - K894241

510(k) Number K894241 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 21, 1989
Decision Date June 18, 1990
Days to Decision 362 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
247d slower than avg
Panel avg: 115d · This submission: 362d
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 K894241.
MODELS 4000,4900,6000,8000,8900,LUXUS 60,100,1700
K902148 · Heraeus Lasersonics, Inc. · Jul 1990
ADD'L USE OF THE KTP/YAG SURGICAL LASER
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MODEL YC-1200/PHOTOCOAGULATOR OPHTHALMIC LASER
K901481 · Nidek, Inc. · Jun 1990
KTP/532 (TM) SURGICAL LASER
K901943 · Laserscope · May 1990
MODELS 4000/4900/6000/8000/8900, LUXAS&1700 ND:YAG
K900630 · Heraeus Lasersonics, Inc. · May 1990
HERAEUS LASERSONICS CO2 WAVEGUIDE DELIVERY SYSTEM
K900751 · Heraeus Lasersonics, Inc. · May 1990