Weights, Eyelid, Implantable
The Implantable Eyelid Weight is a small gold or platinum weight surgically implanted in the upper eyelid to assist in eyelid closure through gravity, used as a treatment for lagophthalmos (incomplete eyelid closure) caused by facial nerve palsy or other conditions. The device uses gravity assistance to facilitate eye closure, protecting the cornea from exposure injury. Classified as FDA Class 2, it requires 510(k) premarket clearance under regulation 886.5700 (Ophthalmic specialty). This device carries the implant flag.
Basic Information
- Product Code
- NCB
- Device Class
- FDA class 2
- Regulation Number
- 886.5700
- Medical Specialty
- Ophthalmic
- Review Panel
- OP
- Submission Type
- 1
Device Characteristics
Definition
Gravity assisted treatment of lagophthalmos (incomplete eyelid closure)
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 1 510(k) clearance via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K203569 | Gold Tapered Weight Eyelid Implants, Platinum Tapered Weight Eyelid Implants | Jun 11, 2021 | Substantially Equivalent | FCI (France Chirurgie Instrumentation) SAS |
FEI Numbers
This FDA classification entry is associated with 3 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 3 registration numbers. Click on an entry to view related FDA registrations.