# K971245: Blink External Eyelid Weight

- Pathway: 510(k) (Traditional)
- Applicant: Ipax, Inc.
- Decided: Jun 20, 1997 after 78 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) Gold Eyelid Implants: named in the summary without a submission number
- (no number) EyeClose External Eyelid Weights: named in the summary without a submission number
- (no number) External Series 1000 External Eyelid Weight (MedDev): named in the summary without a submission number

## Indications for use
Blink External Eyelid Weight are attached with an adhesive tape or gum to the outer surface of the upper eyelid. This weight acts by gravity to restore a functional blink mechanism to the patient who is afflicted with lagophthalmos. Usually the adhesive is changed daily after bathing. 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/K971245
Methodology: https://510kreport.com/methodology