NCB — Weights, Eyelid, Implantable Class II
FDA product code NCB covers "Weights, Eyelid, Implantable", a Class II medical device regulated under 21 CFR 886.5700. Submissions are reviewed by the Ophthalmic panel. Devices under this code are implants. At least 1 recent 510(k) clearance has been granted under this product code.
Classification Details
- Product Code
- NCB
- Device Class
- Class II
- Regulation Number
- 886.5700
- Submission Type
- Review Panel
- OP
- Medical Specialty
- Ophthalmic
- Implant
- Yes
Definition
Gravity assisted treatment of lagophthalmos (incomplete eyelid closure)
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K203569 | fci (france chirurgie instrumentation) | Gold Tapered Weight Eyelid Implants, Platinum Tapered Weight Eyelid Implants | June 11, 2021 |