HQN — Conformer, Ophthalmic Class II
FDA product code HQN covers "Conformer, Ophthalmic", a Class II medical device regulated under 21 CFR 886.3130. Submissions are reviewed by the Ophthalmic panel. At least 7 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- HQN
- Device Class
- Class II
- Regulation Number
- 886.3130
- Submission Type
- Review Panel
- OP
- Medical Specialty
- Ophthalmic
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K972034 | porex surgical | MEDPOR OCULAR CONFORMER | January 20, 1998 |
| K970318 | southwest artificial eyes | OCULAR CONFORMER | July 7, 1997 |
| K970319 | xavier a. guerra, ocularist | OCULAR CONFORMER | July 7, 1997 |
| K945110 | kolberg ocular products | KOLBERG OPHTHALMIC CONFORMER | January 13, 1995 |
| K921221 | storz instrument | STERILE/SINGLE USE SYMBLEPHARON RING | July 17, 1992 |
| K921229 | storz instrument | STERILE/SINGLE USE OPHTHALMIC CONFORMERS | June 9, 1992 |
| K772168 | robert b. scott ocularists of florida | MOLDEYE | November 30, 1977 |