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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 K980398
Device Name KAPLAN PENDULASER 115 SURGICAL LASER WITH OPTOSCAN II
Applicant
Optomedic Medical Technologies , Ltd.
12300 Twinbrook Pkwy., Suite 625
Rockville,  MD  20852
Applicant Contact WHIT ATHEY
Correspondent
Optomedic Medical Technologies , Ltd.
12300 Twinbrook Pkwy., Suite 625
Rockville,  MD  20852
Correspondent Contact WHIT ATHEY
Regulation Number878.4810
Classification Product Code
GEX  
Date Received02/02/1998
Decision Date 09/22/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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