Conformer, Ophthalmic
FDA product code HQN · Class II (moderate risk) · 21 CFR 886.3130 · Ophthalmic
7510(k) clearances
0PMA approvals
1recalls
Manufacturers
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K972034 | Medpor Ocular ConformerHQN · Traditional | Porex Surgical, Inc. | 01/20/1998SE |
| K970319 | Ocular ConformerHQN · Traditional | Xavier A. Guerra, Ocularist, Inc. | 07/07/1997SE |
| K970318 | Ocular ConformerHQN · Traditional | Southwest Artificial Eyes, Inc. | 07/07/1997SE |
| K945110 | Kolberg Ophthalmic ConformerHQN · Traditional | Kolberg Ocular Products, Inc. | 01/13/1995SE |
| K921221 | Sterile/Single Use Symblepharon RingHQN · Traditional | Storz Instrument Co. | 07/17/1992SE |
| K921229 | Sterile/Single Use Ophthalmic ConformersHQN · Traditional | Storz Instrument Co. | 06/09/1992SE |
| K772168 | MoldeyeHQN · Traditional | Robert B. Scott Ocularists of Florida, Inc. | 11/30/1977SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-2302-2008 | Ocular Conformer, Sterile, Porex Surgical Inc., 15 Dart Road, Newnan, GA 30265. The…The Ocular Conformers were distributed with an expired expiration date. | Porex Surgical, Inc. | 03/28/2008Terminated |