Keratoprosthesis, Temporary Implant, Surgical Use
The Temporary Implant Keratoprosthesis for Surgical Use is a temporary artificial cornea implanted intraocularly during vitreoretinal surgery to replace the patient's cornea when optical clarity is compromised, enabling surgical visualization of the posterior segment and then removed at the end of the procedure. Classified as a Class 2 implantable device under 21 CFR 886.3400 within the Ophthalmic specialty, it requires 510(k) premarket notification. It carries an implant flag due to its intraoperative intraocular placement.
Research product code MLP in seconds
The Research Assistant summarizes clearances, adverse event trends and regulation context for a product code — and cites every record.
Free to try · every answer cites its records
Basic Information
- Product Code
- MLP
- Device Class
- FDA class 2
- Regulation Number
- 886.3400
- Medical Specialty
- Ophthalmic
- Review Panel
- OP
- Submission Type
- 1
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 4 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K910828 | LANDERS WIDE FIELD TEMPORARY KERATOPROSTHESIS | Aug 21, 1991 | Substantially Equivalent | Ocular Instruments, Inc. |
| K902491 | ECKHARDT TEMPORARY KERATOPROSTHESIS | Jun 26, 1990 | Substantially Equivalent | Dutch Ophthalmic USA, Inc. |
| K895013 | COBO TEMPORARY KERATOPROSTHESIS | Oct 31, 1989 | Substantially Equivalent | Ocular Instruments, Inc. |
| K842856 | LANDERS-FOULKS TEMP. KERATOPROSTHESIS | Dec 18, 1984 | Substantially Equivalent | Ocular Instruments, Inc. |
FEI Numbers
This FDA classification entry is associated with 1 FEI number. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 1 registration number. Click on an entry to view related FDA registrations.