Cleared Traditional

K894241 - MODEL 20-CH W/ AR-10A/U OPTICAL ATTACHMENT
(FDA 510(k) Clearance)

K894241 · Directed Energy, Inc. · General & Plastic Surgery

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, a Powered Laser Surgical Instrument (Class II — Special Controls, product code GEX), submitted by Directed Energy, Inc. (Los Angeles, US). The FDA issued a Cleared decision on June 18, 1990, 362 days after receiving the submission on June 21, 1989. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4810.

Submission Details

510(k) Number	K894241 FDA.gov
FDA Decision	Cleared 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	—

Device Classification

Product Code	GEX — Powered Laser Surgical Instrument
Device Class	Class II — 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.