FDA.reportPublic FDA data

510(k) K231123

Device
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.
510(k) number
K231123
Product code
LRX
Decision
Substantially Equivalent (SESE)
Decision date
2023-08-30
Date received
2023-04-20
Regulation
886.5928
Classification name
Case, Contact Lens
Medical specialty
Ophthalmic
Review panel
Ophthalmic
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Michael Stuart
Address
El-209, Shil Mahape Rd. Electronic Zone; Midc Ttc Industry Area, Mahape Navi Mumbai IN 400710 400710

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

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510(k), Device, Applicant table
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K131783POLAROID CONTACTSPODViopti, Ltd.2014-02-21
K130930OWL CONTACT LENS CASES, DOG CONTACT LENS CASESNingbo Lishunda Electronics Co., Ltd.2014-02-12