Landers-Foulks Temp. Keratoprosthesis
FDA 510(k) K842856 · Ocular Instruments, Inc.
510(k) numberK842856
Submission
- Device name
- Landers-Foulks Temp. Keratoprosthesis
- Applicant
- Ocular Instruments, Inc.
Bellevue, WA, US - Received
- July 20, 1984
- Decision date
- December 18, 1984
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- MLP – Keratoprosthesis, Temporary Implant, Surgical Use
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 886.3400
- Specialty
- Ophthalmic
- Implant
- Yes
Other 510(k)s with product code MLP
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K261312 | Temporary Keratoprosthesis (QuickSet TKP)MLP · Traditional | Eyekon Medical, Inc. | 07/24/2026SE |
| K910828 | Landers Wide Field Temporary KeratoprosthesisMLP · Traditional | Ocular Instruments, Inc. | 08/21/1991SE |
| K902491 | Eckhardt Temporary KeratoprosthesisMLP · Traditional | Dutch Ophthalmic USA, Inc. | 06/26/1990SE |
| K895013 | Cobo Temporary KeratoprosthesisMLP · Traditional | Ocular Instruments, Inc. | 10/31/1989SE |
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| K933976 | Mandelkorn Suture Lysis LensHJK · Traditional | 11/08/1994SE |
| K933264 | Ritch Nylon Suture Laser LensHJK · Traditional | 10/31/1994SE |
| K941420 | 50 Degree Hri Prism LensHJK · Traditional | 08/29/1994SE |
| K935302 | Osher Surgical Gonio/Posterior Pole LensHKS · Traditional | 04/01/1994SE |
| K923670 | Byrne Expulsive LensHJI · Traditional | 11/16/1992SE |
| K921414 | Trokel /3 Gonio Laser LensLQJ · Traditional | 11/16/1992SE |
| K914051 | Pediatric Vitrectomy Lens SetHJK · Traditional | 12/09/1991SE |
| K914117 | Landers High Refractive Index Vitrectomy Lens SetHJK · Traditional | 11/13/1991SE |
Questions and answers
When was Landers-Foulks Temp. Keratoprosthesis cleared by the FDA?
Landers-Foulks Temp. Keratoprosthesis (K842856) received a 510(k) decision of Substantially Equivalent on December 18, 1984, 151 days after the submission was received.
What is the product code of K842856?
The FDA product code is MLP – Keratoprosthesis, Temporary Implant, Surgical Use, a Class II (moderate risk) device regulated under 21 CFR 886.3400.