Cleared Traditional

K870970 - MODEL 10-C WITH AN SA-10B/U OPTICAL ATTACHMENT
(FDA 510(k) Clearance)

K870970 · Directed Energy, Inc. · General & Plastic Surgery device

May 1987

Decision

77d

Days

Class 2

Risk

K870970 is an FDA 510(k) clearance for the MODEL 10-C WITH AN SA-10B/U OPTICAL ATTACHMENT. This device is classified as 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 May 26, 1987, 77 days after receiving the submission on March 10, 1987.

This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4810. 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..

Submission Details

510(k) Number	K870970 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	March 10, 1987
Decision Date	May 26, 1987
Days to Decision	77 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.