Temporary Keratoprosthesis (QuickSet TKP™)
FDA 510(k) clearance K261312 · decided 2026-07-24
Clearance details
- K-number
- K261312
- Device name
- Temporary Keratoprosthesis (QuickSet TKP™)
- Applicant
- Eyekon Medical, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2026-04-21
- Decision date
- 2026-07-24
- Days to decision
- 94 days
- Clearance type
- Traditional
- Product code
- MLP
- Device class
- 2
- Regulation number
- 886.3400
- Medical specialty
- Ophthalmic
- Advisory committee
- Ophthalmic
- Location
- Clearwater, FL, US
- 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.
| Record | Firm | Date |
|---|---|---|
| LANDERS WIDE FIELD TEMPORARY KERATOPROSTHESIS (K910828) | Ocular Instruments, Inc. | 1991-08-21 |
| ECKHARDT TEMPORARY KERATOPROSTHESIS (K902491) | Dutch Ophthalmic USA, Inc. | 1990-06-26 |
| COBO TEMPORARY KERATOPROSTHESIS (K895013) | Ocular Instruments, Inc. | 1989-10-31 |
| LANDERS-FOULKS TEMP. KERATOPROSTHESIS (K842856) | Ocular Instruments, Inc. | 1984-12-18 |
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| POSTERIOR CHAMBER INTRAOCULAR LENS (P880072/S047) | Eyekon Medical, Inc. | 2000-06-20 |
| TC65B-SUV (P880072/S044) | Eyekon Medical, Inc. | 1997-04-15 |
| TC65B-SUV (P880072/S045) | Eyekon Medical, Inc. | 1997-03-13 |
| POSTERIOR CHAMBER INTRAOCULAR LENSES MODELS PA38E-OUV AND PL52A-OUV (P880072/S042) | Eyekon Medical, Inc. | 1996-04-24 |
| MODELS GL65C-OUV ULTRAVIOLET-ABSORBING POSTERIOR CHAMBER INTRAOCULAR LENS (IOL) (P880072/S040) | Eyekon Medical, Inc. | 1996-04-17 |
| MODEL PA48A-OUV ULTRAVIOLET-ABSORBING POSTERIOR CHAMBER INTRAOCULAR LENS (IOL) (P880072/S039) | Eyekon Medical, Inc. | 1996-04-08 |
| MODIFIED J-LOOP POSTERIOR CHAMBER IOL (P880072/S036) | Eyekon Medical, Inc. | 1996-02-12 |
| MODIFIED J & C LOOP MODEL PA36 POSTERIOR CHAMBER INTRAOCULAR LENS (P880072/S037) | Eyekon Medical, Inc. | 1995-11-01 |