Clearance Summary
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) received FDA 510(k) clearance under submission number K231123, sponsored by Phoenix Innovative Healthcare Manufacturers Pvt. , Ltd.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Ophthalmic review panel. The statutory decision date of record is 2023-08-30.
- Submission: K231123
- Applicant / Sponsor: Phoenix Innovative Healthcare Manufacturers Pvt. , Ltd.
- Clearance pathway: Traditional
- Review panel: Ophthalmic
- Device class: Class II
- Regulation citation: 21 CFR 886.5928
- Decision date: 2023-08-30
Classification & Regulation
This clearance is catalogued under FDA product code LRX and 21 CFR 886.5928, within the Ophthalmic review panel as a Class II device.