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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Lens, Spectacle, Non-Custom (Prescription)
510(k) Number K812051
Device Name PHOTOLITE AOLITE TINTOMATIC LENS
Applicant
American Optical Corp.
4221 Richmond Rd., NW
Walker,  MI  49534
Correspondent
American Optical Corp.
4221 Richmond Rd., NW
Walker,  MI  49534
Regulation Number886.5844
Classification Product Code
HQG  
Date Received07/21/1981
Decision Date 09/08/1981
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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