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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 K863367
Device Name FORMALENS 2000
Applicant
Vision-Sciences, Inc.
140 E. Duarte Rd.
Monrovia,  CA  91016
Applicant Contact HOWARD SILVERMAN
Correspondent
Vision-Sciences, Inc.
140 E. Duarte Rd.
Monrovia,  CA  91016
Correspondent Contact HOWARD SILVERMAN
Regulation Number886.5844
Classification Product Code
HQG  
Date Received09/03/1986
Decision Date 09/26/1986
Decision SUBSTANTIALLY EQUIVALENT FOR SOME INDICATIONS (SN)
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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