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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 K882814
Device Name NEOLENS PRESCRIPTION SPECTACLE LENS
Applicant
Neolens, Inc.
18963 NE 4th Ct.
Miami,  FL  33179
Applicant Contact CLAYMAN, MD
Correspondent
Neolens, Inc.
18963 NE 4th Ct.
Miami,  FL  33179
Correspondent Contact CLAYMAN, MD
Regulation Number886.5844
Classification Product Code
HQG  
Date Received07/08/1988
Decision Date 07/29/1988
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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