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)
FDA 510(k) clearance K231123 · decided 2023-08-30
Clearance details
- 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.
- Decision
- Substantially Equivalent
- Date received
- 2023-04-20
- Decision date
- 2023-08-30
- Days to decision
- 132 days
- Clearance type
- Traditional
- Product code
- LRX
- Device class
- 2
- Regulation number
- 886.5928
- Medical specialty
- Ophthalmic
- Advisory committee
- Ophthalmic
- Location
- Navi Mumbai, IN
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
Recalls involving this device
No recalls on record reference this clearance.