QWU — Prosthesis, Eyelid Spacer/Graft, Polymer Class II
FDA product code QWU covers "Prosthesis, Eyelid Spacer/Graft, Polymer", a Class II medical device regulated under 21 CFR 886.3130. 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
- QWU
- Device Class
- Class II
- Regulation Number
- 886.3130
- Submission Type
- Review Panel
- OP
- Medical Specialty
- Ophthalmic
- Implant
- Yes
Definition
For implantation to reinforce and aid in reconstruction of the soft tissues of the eyelid and eyelid area.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K223074 | corneat vision | CorNeat EverPatch | June 2, 2023 |