K000127 is an FDA 510(k) clearance for the KURZ PURE GOLD UPPER EYELIDS IMPLANT (OBERASCHER), MODEL 4001 02-4001 10. This device is classified as a Weights, Eyelid, External (Class II - Special Controls, product code MML).
Submitted by Heinz Kurz GmbH Medizintechnik (Amsterdam, Nh, NL). The FDA issued a Cleared decision on April 12, 2000, 85 days after receiving the submission on January 18, 2000.
This device falls under the Ophthalmic FDA review panel. Regulated under 21 CFR 886.5700. Gravity Assisted Treatment Of Lagophthalmos (incomplete Eyelid Closure).
| 510(k) Number | K000127 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 18, 2000 |
| Decision Date | April 12, 2000 |
| Days to Decision | 85 days |
| Submission Type | Traditional |
| Review Panel | Ophthalmic (OP) |
| Summary | Summary PDF |
| Product Code | MML — Weights, Eyelid, External |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 886.5700 |
| Definition | Gravity Assisted Treatment Of Lagophthalmos (incomplete Eyelid Closure) |