NQB — Conformer, Ophthalmic, Biological Tissue Class II
FDA product code NQB covers "Conformer, Ophthalmic, Biological Tissue", 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
- NQB
- Device Class
- Class II
- Regulation Number
- 886.3130
- Submission Type
- Review Panel
- OP
- Medical Specialty
- Ophthalmic
- Implant
- Yes
Definition
The ophthalmic conformer with molded plastic and biological tissue insert is introduced temporarily between the eyeball and eyelid to maintain space in the orbital cavity, prevent closure or adhesions during the healing process following surgery, and enables positioning of biological tissue to the ocular surface without the need for sutures.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K032104 | bio-tissue | AMNIOLENS | December 12, 2003 |