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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 K901786
Device Name LASEGUIDE CAT # CLF-600D & CLF-1000D
Applicant
Laser Peripherals, LLC
35 Pond Park Rd. #9
Hingham,  MA  02043
Applicant Contact J PIETRAFITTA
Correspondent
Laser Peripherals, LLC
35 Pond Park Rd. #9
Hingham,  MA  02043
Correspondent Contact J PIETRAFITTA
Regulation Number878.4810
Classification Product Code
GEX  
Date Received04/18/1990
Decision Date 06/27/1990
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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