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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Laser, Ophthalmic
510(k) Number K910612
Device Name CANDELA DIODE TRABECULOPLASTY LASER DTL
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 Number886.4390
Classification Product Code
HQF  
Date Received02/12/1991
Decision Date 03/04/1991
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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