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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Lens, Contact (Other Material) - Daily
510(k) Number K172314
Device Name Ampleye Scleral RGP Lens (roflufocon D, roflufocon E, hexafocon A, paflufocon D)
Applicant
Art Optical Contact Lens Inc
3175 3 Mile Rd NW
Grand Rapids,  MI  49534
Applicant Contact Mike Johnson
Correspondent
EyeReg Consulting, Inc.
6119 Canter Ln
West Linn,  OR  97068
Correspondent Contact Bret Andre
Regulation Number886.5916
Classification Product Code
HQD  
Date Received08/01/2017
Decision Date 09/20/2017
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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