HPC
13 FDA 510(k) clearances · Product code
70 daysmedian time to decision
254 days90th percentile
13clearances measured
FDA profile
- Official device name
- Set, Lens, Trial, Ophthalmic
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 886.1405
- Medical specialty
- Ophthalmic
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| BOBES LENS SET (K945443) | Bobes S.A. | 1995-07-19 |
| OTI MODEL TLS-60 (K951437) | Oti Medical, LLC | 1995-04-11 |
| OPHTHALMIC TRIAL LENSES (K930195) | Optimark Accessories and Instruments | 1994-01-06 |
| CONTACT LENSES (K934859) | Arno Intl., Inc. | 1993-12-21 |
| MARCO TRIAL SETS (K930446) | Marco Ophthalmic, Inc. | 1993-07-06 |
| BURTON TRIAL LENS SET (K924786) | R.H. Burton Co. | 1993-04-14 |
| TRIAL LENS SET (K920571) | R.H. Burton Co. | 1992-05-07 |
| WOODLYN FULL APERTURE TRIAL LENS SET (K900478) | Woodlyn, Inc. | 1990-02-21 |
| CONFIRMATION TESTS (K873907) | Richmond Products, Inc. | 1987-12-29 |
| ACC CROSS CYLINDERS (K852056) | Ascon Medical Instruments, Ltd. | 1985-06-05 |
| TRIA LENS SET (K843095) | Optek Medico Co., Ltd. | 1984-10-05 |
| WOODLYN CLASSIC TRIAL LENS SET (K841766) | Woodlyn, Inc. | 1984-06-01 |
| LENS SET, MENTOR TRIAL (K770389) | Codman & Shurtleff, Inc. | 1977-03-14 |
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Every clearance here is in the API, with alerts when new ones post.