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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Case, Contact Lens
510(k) Number K231123
Device Name Phoenix Contact Lens Case - dome top flat pack (CL-01); Phoenix Contact Lens Case - classic flat pack (CL-02); Phoenix Contact Lens Case - sunglass shape flat pack (CL-03)
Applicant
Phoenix Innovative Healthcare Manufacturers Pvt. , Ltd.
El-209, Shil Mahape Rd. Electronic Zone;
Midc Ttc Industry Area, Mahape
Navi Mumbai,  IN 400710
Applicant Contact Michael Stuart
Correspondent
Phoenix Innovative Healthcare Manufacturers Pvt. , Ltd.
El-209, Shil Mahape Rd. Electronic Zone;
Midc Ttc Industry Area, Mahape
Navi Mumbai,  IN 400710
Correspondent Contact Michael Stuart
Regulation Number886.5928
Classification Product Code
LRX  
Date Received04/20/2023
Decision Date 08/30/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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