K940974 is an FDA 510(k) clearance for the EYECLOSE EXTERNAL EYELID WEIGHTS. This device is classified as a Weights, Eyelid, External (Class II - Special Controls, product code MML).
Submitted by Meddev Corp. (Los Altos, US). The FDA issued a Cleared decision on June 8, 1994, 97 days after receiving the submission on March 3, 1994.
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 | K940974 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 03, 1994 |
| Decision Date | June 08, 1994 |
| Days to Decision | 97 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) |