510(k) K231123
K231123 is an FDA 510(k) premarket notification submitted by Phoenix Innovative Healthcare Manufacturers Pvt. , Ltd. for the 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)". The FDA issued a decision of Substantially Equivalent on August 30, 2023. The device falls under product code LRX (Case, Contact Lens), a Class II device regulated under 21 CFR 886.5928. Phoenix Innovative Healthcare Manufacturers Pvt. , Ltd. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 30, 2023
- Date Received
- April 20, 2023
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Case, Contact Lens
- Device Class
- Class II
- Regulation Number
- 886.5928
- Review Panel
- OP
- Submission Type