Phoenix Contact Lens Case - dome top flat pack - Phoenix Contact Lens Case - classic flat pack (CL-02)

FDA 510(k)

Class II (US FDA 510(k))

510(k) K231123

by Phoenix Innovative Healthcare Manufacturers Pvt. Ltd.

Identifiers

510(k) Number: K231123 FDA 510(k)
FDA Product Code: LRX FDA 510(k)
Models / Variants: Phoenix Contact Lens Case - dome top flat pack (CL-01) FDA 510(k)
Phoenix Contact Lens Case - classic flat pack (CL-02) FDA 510(k)
Phoenix Contact Lens Case - sunglass shape flat pack (CL-03) FDA 510(k)

Classification

Device Class: Class II FDA 510(k)
Legislation / Framework: 21 CFR Part 886.5928 FDA 510(k)
Regulation Number: 886.5928 FDA 510(k)
Advisory Committee: Ophthalmic FDA 510(k)
FDA Decision: SESE Substantially Equivalent FDA 510(k)

The Phoenix Contact Lens Case is a storage device for contact lenses, available in three styles: dome top flat pack (CL-01), classic flat pack (CL-02), and sunglass shape flat pack (CL-03). It is designed for storing soft (hydrophilic), rigid gas permeable, and hard contact lenses during chemical disinfection.

The device is supplied by Phoenix Innovative Healthcare Manufacturers Pvt. Ltd. and has received FDA 510(k) clearance with the number K231123. It is classified as a Class II medical device under product code LRX for ophthalmic use. The device is not indicated for MRI safety and is available in multiple sizes as specified by the model numbers.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Phoenix Contact Lens Case - dome top flat pack (CL-01); Phoenix Contact ..., Phoenix Contact Deutschland, K231123 - Phoenix Contact Lens Case - dome top flat pack..., Phoenix Contact Lens Case - dome top flat pack… - FDA.report

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

Source	Region	Type	Cert / Approval No.	Class	Status
FDA 510(k)	United States	FDA_510K	K231123	Class II	Active

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Manufacturer

Manufacturer: Phoenix Innovative Healthcare Manufacturers Pvt. Ltd.
FDA Applicant: Phoenix Innovative Healthcare Manufacturers Pvt. , Ltd.

Sources (1)

FDA 510(k) K231123 24 fields · synced Oct 6, 2026