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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear)
510(k) Number K852404
Device Name LASERSAFE EYE SHIELDS
Applicant
Lasersafe, Inc.
641 Ridgefield Ave.
Pittsburgh,  PA  15216
Applicant Contact TEEPLE, M.D.
Correspondent
Lasersafe, Inc.
641 Ridgefield Ave.
Pittsburgh,  PA  15216
Correspondent Contact TEEPLE, M.D.
Regulation Number886.4750
Classification Product Code
HOY  
Date Received06/06/1985
Decision Date 10/04/1985
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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