K971242 is an FDA 510(k) clearance for the BLINK GOLD EVELID WEIGHT (BG 06 THRU BG 28). 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 December 17, 1997, 259 days after receiving the submission on April 2, 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 | K971242 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 02, 1997 |
| Decision Date | December 17, 1997 |
| Days to Decision | 259 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) |