# K971242: Blink Gold Evelid Weight (BG 06 Thru BG 28)

- Pathway: 510(k) (Traditional)
- Applicant: Ipax, Inc.
- Decided: Dec 17, 1997 after 259 days
- Product code: MML (Weights, Eyelid, External)
- Device class: 2
- Regulation: 21 CFR 886.5700
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Series 3000 Gold Eyelid Implant: named in the summary without a submission number

## Indications for use
Blink Gold Eyelid Weight Implants, surgical implanted in the upper eyelid, work by gravity to restore a functional blink mechanism in the patient with Iagopt)thalmos resulting from temporary or permanent facial paralysis, specifically the orbicularis oculi muscle. This paralysis may be the result of Bell's palsy or from surgical trauma to the facial nerve. The patient with lagophthalmos is unable to close the eyelid completely because of partial or complete paralysis to the facial nerve. This paralysis may be the result of Bell's palsy or from surgical trauma to the facial nerve. The condition of paralysis can be either permanent or transient.

Source page: https://510kreport.com/device/K971242
Methodology: https://510kreport.com/methodology