K971245 is an FDA 510(k) clearance for the BLINK EXTERNAL EYELID WEIGHT. This device is classified as a Weights, Eyelid, External (Class II - Special Controls, product code MML).
Submitted by Ipax, Inc. (Englewood, US). The FDA issued a Cleared decision on June 20, 1997, 78 days after receiving the submission on April 3, 1997.
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 | K971245 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 03, 1997 |
| Decision Date | June 20, 1997 |
| Days to Decision | 78 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) |