FDA Product Code
FDA Product Code HPC — Clearance Directory
- Device Class
- Class I
- Assigned Panel
- Ophthalmic
- 21 CFR Citation
- 886.1405
510(k) Clearances — 13 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K945443 | BOBES LENS SET | Bobes S.A. | 1995-07-19 | Traditional | PDF ↗ |
| K951437 | OTI MODEL TLS-60 | Oti Medical, LLC | 1995-04-11 | Traditional | PDF ↗ |
| K930195 | OPHTHALMIC TRIAL LENSES | Optimark Accessories and Instruments | 1994-01-06 | Traditional | PDF ↗ |
| K934859 | CONTACT LENSES | Arno Intl., Inc. | 1993-12-21 | Traditional | PDF ↗ |
| K930446 | MARCO TRIAL SETS | Marco Ophthalmic, Inc. | 1993-07-06 | Traditional | PDF ↗ |
| K924786 | BURTON TRIAL LENS SET | R.H. Burton Co. | 1993-04-14 | Traditional | PDF ↗ |
| K920571 | TRIAL LENS SET | R.H. Burton Co. | 1992-05-07 | Traditional | PDF ↗ |
| K900478 | WOODLYN FULL APERTURE TRIAL LENS SET | Woodlyn, Inc. | 1990-02-21 | Traditional | PDF ↗ |
| K873907 | CONFIRMATION TESTS | Richmond Products, Inc. | 1987-12-29 | Traditional | PDF ↗ |
| K852056 | ACC CROSS CYLINDERS | Ascon Medical Instruments, Ltd. | 1985-06-05 | Traditional | PDF ↗ |
| K843095 | TRIA LENS SET | Optek Medico Co., Ltd. | 1984-10-05 | Traditional | PDF ↗ |
| K841766 | WOODLYN CLASSIC TRIAL LENS SET | Woodlyn, Inc. | 1984-06-01 | Traditional | PDF ↗ |
| K770389 | LENS SET, MENTOR TRIAL | Codman & Shurtleff, Inc. | 1977-03-14 | Traditional | PDF ↗ |
Product code HPC · Class I · Ophthalmic. Data: openFDA.