K011740 is an FDA 510(k) clearance for the CONTOUR DESIGN GOLD EYELID IMPLANT, MODEL CONTOUR DESIGN (SERIES 3000). This device is classified as a Weights, Eyelid, External (Class II - Special Controls, product code MML).
Submitted by Meddev Corp. (Sunnyvale, US). The FDA issued a Cleared decision on July 2, 2001, 27 days after receiving the submission on June 5, 2001.
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 | K011740 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 05, 2001 |
| Decision Date | July 02, 2001 |
| Days to Decision | 27 days |
| Submission Type | Special |
| 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) |