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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 K920553
Device Name MYRIADLASE SIDEFIRE-TIPPED OPTICAL FIBER
Applicant
Myriad Lase, Inc.
4800 SE Loop 820
Forest Hill,  TX  76140
Applicant Contact H. A LAWHON
Correspondent
Myriad Lase, Inc.
4800 SE Loop 820
Forest Hill,  TX  76140
Correspondent Contact H. A LAWHON
Regulation Number878.4810
Classification Product Code
GEX  
Date Received02/06/1992
Decision Date 03/26/1992
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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