QWU
- Product code
- QWU
- Device name
- Prosthesis, Eyelid Spacer/Graft, Polymer
- Device class
- Class 2
- 21 CFR
- 21 CFR 886.3130
- Medical specialty
- Ophthalmic
- Marketing pathway
- 510(K) Exempt
- Flag
- Implant
- 510(k) clearances (all years, FDA)
- 1 (all years; only the last 3 years are listed here)
FDA classification definition
For implantation to reinforce and aid in reconstruction of the soft tissues of the eyelid and eyelid area.
Official FDA classification page: QWU
Classification and pathway per current FDA publications. Data from openFDA (CC0).