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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 K901710
Device Name OPTICA 120 ND:YAG SURGICAL LASER SYSTEM
Applicant
Xintec Corporation
900 Alice St.
Oakland,  CA  94607
Applicant Contact CHOU, PHD
Correspondent
Xintec Corporation
900 Alice St.
Oakland,  CA  94607
Correspondent Contact CHOU, PHD
Regulation Number878.4810
Classification Product Code
GEX  
Date Received04/13/1990
Decision Date 09/20/1990
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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