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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Camera, Ophthalmic, Ac-Powered
510(k) Number K913314
Device Name CANDELA RETINAL CAMERA
Applicant
Candela Laser Corp.
530 Boston Post Rd.
Wayland,  MA  01778
Applicant Contact GEORGE CHO
Correspondent
Candela Laser Corp.
530 Boston Post Rd.
Wayland,  MA  01778
Correspondent Contact GEORGE CHO
Regulation Number886.1120
Classification Product Code
HKI  
Date Received07/25/1991
Decision Date 01/23/1992
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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