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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 K873664
Device Name LIGHT-SPOT FIBEROPTIC LASER HANDPIECE
Applicant
Laserguide
51 Santa Felicia Dr.
Santa Barbara,  CA  93117
Applicant Contact ROBERT MICHAELS
Correspondent
Laserguide
51 Santa Felicia Dr.
Santa Barbara,  CA  93117
Correspondent Contact ROBERT MICHAELS
Regulation Number878.4810
Classification Product Code
GEX  
Date Received09/10/1987
Decision Date 11/06/1987
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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