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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 K914396
Device Name SURGI LIGHT NON-CONTACT FIBERS
Applicant
Lifestream Int'L, Inc.
2828 N.Crescent River Dr.
The Woodlands,  TX  77381
Applicant Contact KRISTA OAKES
Correspondent
Lifestream Int'L, Inc.
2828 N.Crescent River Dr.
The Woodlands,  TX  77381
Correspondent Contact KRISTA OAKES
Regulation Number878.4810
Classification Product Code
GEX  
Date Received10/01/1991
Decision Date 12/23/1991
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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