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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 K062336
Device Name OPTIMEDICA LASER INDIRECT OPHTHALMOSCOPE
Applicant
Optimedica Corporation
733 Bolsana Dr.
Laguna Beach,  CA  92651
Applicant Contact JUDY F GORDON
Correspondent
Optimedica Corporation
733 Bolsana Dr.
Laguna Beach,  CA  92651
Correspondent Contact JUDY F GORDON
Regulation Number878.4810
Classification Product Code
GEX  
Date Received08/10/2006
Decision Date 10/19/2006
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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