510(k) K261312
- Device
- Temporary Keratoprosthesis (QuickSet TKP™)
- Applicant
- Eyekon Medical, Inc.
- 510(k) number
- K261312
- Product code
- MLP
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2026-07-24
- Date received
- 2026-04-21
- Regulation
- 886.3400
- Classification name
- Keratoprosthesis, Temporary Implant, Surgical Use
- Medical specialty
- Ophthalmic
- Review panel
- Ophthalmic
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- N
Applicant Contact#
- Contact
- Mark Robinson
- Address
- 2451 Enterprise Rd. Clearwater FL US 33763 33763
FDA Registration Numbers#
- 1038833
- 3014865
Source Documents#
Other 510(k) Records For Product Code MLP#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K910828 | LANDERS WIDE FIELD TEMPORARY KERATOPROSTHESIS | Ocular Instruments, Inc. | 1991-08-21 |
| K902491 | ECKHARDT TEMPORARY KERATOPROSTHESIS | Dutch Ophthalmic USA, Inc. | 1990-06-26 |
| K895013 | COBO TEMPORARY KERATOPROSTHESIS | Ocular Instruments, Inc. | 1989-10-31 |
| K842856 | LANDERS-FOULKS TEMP. KERATOPROSTHESIS | Ocular Instruments, Inc. | 1984-12-18 |