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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 K882951
Device Name CO2 SURGICAL LASER SYSTEM MODEL #IR105
Applicant
Niic U.S.A., Inc.
460 Seaport Ct., Suite 101
Redwood City,  CA  94063
Applicant Contact JUN NISHIMURA
Correspondent
Niic U.S.A., Inc.
460 Seaport Ct., Suite 101
Redwood City,  CA  94063
Correspondent Contact JUN NISHIMURA
Regulation Number878.4810
Classification Product Code
GEX  
Date Received07/14/1988
Decision Date 11/02/1988
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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