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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 K000727
Device Name BUFFLIGHT CLT SURGICAL LASER SYSTEM
Applicant
Y-Beam Technologies, Inc.
18732 Saginaw
Irvine,  CA  92612
Applicant Contact JUDY F GORDON
Correspondent
Y-Beam Technologies, Inc.
18732 Saginaw
Irvine,  CA  92612
Correspondent Contact JUDY F GORDON
Regulation Number878.4810
Classification Product Code
GEX  
Date Received03/06/2000
Decision Date 09/19/2000
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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