Panels › Ophthalmic › Product code HPC · Class 1
Set, Lens, Trial, Ophthalmic
Regulation 886.1405
0510(k)s in 12 months (13 all time)
0recalls in 12 months (0 all time)
0recalls that name a 510(k)
Top companies in HPC
| Company | 510(k)s | Recalls |
|---|---|---|
| R.H. Burton Co. | 2 | 0 |
| Woodlyn, Inc. | 2 | 0 |
| Arno Intl., Inc. | 1 | 0 |
| Ascon Medical Instruments, Ltd. | 1 | 0 |
| Bobes S.A. | 1 | 0 |
| Codman & Shurtleff, Inc. | 1 | 0 |
| Marco Ophthalmic, Inc. | 1 | 0 |
| Optek Medico Co., Ltd. | 1 | 0 |
| Optimark Accessories and Instruments | 1 | 0 |
| Oti Medical, LLC | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jul 19, 1995 | K945443 | BOBES LENS SET Bobes S.A., ES | HPC |
| Apr 11, 1995 | K951437 | OTI MODEL TLS-60 Oti Medical, LLC | HPC |
| Jan 6, 1994 | K930195 | OPHTHALMIC TRIAL LENSES Optimark Accessories and Instruments | HPC |
| Dec 21, 1993 | K934859 | CONTACT LENSES Arno Intl., Inc. | HPC |
| Jul 6, 1993 | K930446 | MARCO TRIAL SETS Marco Ophthalmic, Inc. | HPC |
| Apr 14, 1993 | K924786 | BURTON TRIAL LENS SET R.H. Burton Co. | HPC |
| May 7, 1992 | K920571 | TRIAL LENS SET R.H. Burton Co. | HPC |
| Feb 21, 1990 | K900478 | WOODLYN FULL APERTURE TRIAL LENS SET Woodlyn, Inc. | HPC |
| Dec 29, 1987 | K873907 | CONFIRMATION TESTS Richmond Products, Inc. | HPC |
| Jun 5, 1985 | K852056 | ACC CROSS CYLINDERS Ascon Medical Instruments, Ltd. | HPC |
| Oct 5, 1984 | K843095 | TRIA LENS SET Optek Medico Co., Ltd. | HPC |
| Jun 1, 1984 | K841766 | WOODLYN CLASSIC TRIAL LENS SET Woodlyn, Inc. | HPC |
| Mar 14, 1977 | K770389 | LENS SET, MENTOR TRIAL Codman & Shurtleff, Inc. | HPC |
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