← FDA Medical Device Classifications
Prosthesis, Eyelid Spacer/Graft, Polymer
QWU · Class II — Moderate Risk (510(k) clearance required) · Ophthalmic · 21 CFR 886.3130
Classification
- FDA Product Code
QWU- Device class
- Class II — Moderate Risk (510(k) clearance required)
- Regulation
- 21 CFR 886.3130
- Review panel
- OP
- Medical specialty
- Ophthalmic
- Submission type
- 4
- GMP exempt
- N
- Life sustaining
- N
- Implant
- Y
- Third-party review
- N
Definition
For implantation to reinforce and aid in reconstruction of the soft tissues of the eyelid and eyelid area.
Market data
- Cleared 510(k) submissions
- 1
- Registered establishments
- 2
Source
- Authoritative
- FDA Device Classification database
- Machine
- JSON-LD · Markdown