Set, Lens, Trial, Ophthalmic
FDA product code HPC · Class I (low risk) · 21 CFR 886.1405 · Ophthalmic
13510(k) clearances
0PMA approvals
0recalls
Manufacturers
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K945443 | Bobes Lens SetHPC · Traditional | Bobes S.A. | 07/19/1995SE |
| K951437 | Oti Model TLS-60HPC · Traditional | Oti Medical, LLC | 04/11/1995SE |
| K930195 | Ophthalmic Trial LensesHPC · Traditional | Optimark Accessories and Instruments | 01/06/1994SE |
| K934859 | Contact LensesHPC · Traditional | Arno Intl., Inc. | 12/21/1993SE |
| K930446 | Marco Trial SetsHPC · Traditional | Marco Ophthalmic, Inc. | 07/06/1993SE |
| K924786 | Burton Trial Lens SetHPC · Traditional | R.H. Burton Co. | 04/14/1993SE |
| K920571 | Trial Lens SetHPC · Traditional | R.H. Burton Co. | 05/07/1992SE |
| K900478 | Woodlyn Full Aperture Trial Lens SetHPC · Traditional | Woodlyn, Inc. | 02/21/1990SE |
| K873907 | Confirmation TestsHPC · Traditional | Richmond Products, Inc. | 12/29/1987SE |
| K852056 | Acc Cross CylindersHPC · Traditional | Ascon Medical Instruments, Ltd. | 06/05/1985SE |
| K843095 | Tria Lens SetHPC · Traditional | Optek Medico Co., Ltd. | 10/05/1984SE |
| K841766 | Woodlyn Classic Trial Lens SetHPC · Traditional | Woodlyn, Inc. | 06/01/1984SE |
| K770389 | Lens Set, Mentor TrialHPC · Traditional | Codman & Shurtleff, Inc. | 03/14/1977SE |