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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Powered Laser Surgical Instrument
510(k) Number K950313
Device Name KAPLAN PENDULASER 115 - A 15W CO2 SURGICAL LASER
Applicant
Optomedic Medical Technologies , Ltd.
12300 Twinbrook Pkwy., Suite 625
Rockville,  MD  20852
Applicant Contact ALEX HAREL
Correspondent
Optomedic Medical Technologies , Ltd.
12300 Twinbrook Pkwy., Suite 625
Rockville,  MD  20852
Correspondent Contact ALEX HAREL
Regulation Number878.4810
Classification Product Code
GEX  
Date Received01/26/1995
Decision Date 03/24/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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