FDA product code HPC: Set, Lens, Trial, Ophthalmic
HPC is the FDA product code for set, lens, trial, ophthalmic. It is a Class I device, regulated under 21 CFR 886.1405 and reviewed by the Ophthalmic panel. FDA has cleared 13 510(k) submissions under HPC, from 11 different applicants. The average 510(k) review took 108 days (median 70).
Classification
| Field | Value |
|---|---|
| Device name | Set, Lens, Trial, Ophthalmic |
| Device class | Class I |
| Regulation | 21 CFR 886.1405 |
| Review panel | OP — Ophthalmic |
| Medical specialty | Ophthalmic |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every HPC clearance
Top HPC applicants
| Applicant | Clearances | Latest |
|---|---|---|
| R.H. Burton Co. | 2 | 1993-04-14 |
| Woodlyn, Inc. | 2 | 1990-02-21 |
| Bobes S.A. | 1 | 1995-07-19 |
| Oti Medical, LLC | 1 | 1995-04-11 |
| Optimark Accessories and Instruments | 1 | 1994-01-06 |
6 more applicants have HPC clearances. See the full list in Caduvo.
Most recent HPC clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K945443 | Bobes S.A. | BOBES LENS SET | 1995-07-19 | 254 |
| K951437 | Oti Medical, LLC | OTI MODEL TLS-60 | 1995-04-11 | 15 |
| K930195 | Optimark Accessories and Instruments | OPHTHALMIC TRIAL LENSES | 1994-01-06 | 357 |
| K934859 | Arno Intl., Inc. | CONTACT LENSES | 1993-12-21 | 70 |
| K930446 | Marco Ophthalmic, Inc. | MARCO TRIAL SETS | 1993-07-06 | 161 |
Recalls for HPC devices
openFDA lists no recalls for product code HPC.
Frequently asked questions
What is FDA product code HPC?
HPC is the FDA product code for set, lens, trial, ophthalmic. It is a Class I device, regulated under 21 CFR 886.1405 and reviewed by the Ophthalmic panel.
What device class is HPC?
Class I, regulation 21 CFR 886.1405. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code HPC?
Across 13 cleared submissions the average was 108 days from receipt to decision (median 70).
Which companies have the most HPC clearances?
R.H. Burton Co. (2); Woodlyn, Inc. (2); Bobes S.A. (1); Oti Medical, LLC (1); Optimark Accessories and Instruments (1).
Next steps
- Run an FDA pathway report with predicate devices for product code HPC
- Run a recall and safety report across every HPC manufacturer
- Watch product code HPC for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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