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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 K021304
Device Name PROLITE PULSED LIGHT SYSTEM
Applicant
Big Sky Laser Technologies, Inc.
601 Haggerty Ln., Suite C
P.O. Box 8100
Bozeman,  MT  59715
Applicant Contact PATRICK MAINE
Correspondent
Big Sky Laser Technologies, Inc.
601 Haggerty Ln., Suite C
P.O. Box 8100
Bozeman,  MT  59715
Correspondent Contact PATRICK MAINE
Regulation Number878.4810
Classification Product Code
GEX  
Date Received04/24/2002
Decision Date 07/23/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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