FDA product code HPY: Unit, Electrolysis, Battery-Powered, Ophthalmic
HPY is the FDA product code for unit, electrolysis, battery-powered, ophthalmic. It is a Class I device, regulated under 21 CFR 886.4250 and reviewed by the Ophthalmic panel. FDA has cleared 1 510(k) submission under HPY. The average 510(k) review took 97 days (median 97).
Classification
| Field | Value |
|---|---|
| Device name | Unit, Electrolysis, Battery-Powered, Ophthalmic |
| Device class | Class I |
| Regulation | 21 CFR 886.4250 |
| Review panel | OP — Ophthalmic |
| Medical specialty | Ophthalmic |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every HPY clearance
Top HPY applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Teknar, Inc. | 1 | 1990-11-19 |
Most recent HPY clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K903666 | Teknar, Inc. | OPHTHASONIC A/P III | 1990-11-19 | 97 |
Recalls for HPY devices
openFDA lists no recalls for product code HPY.
Frequently asked questions
What is FDA product code HPY?
HPY is the FDA product code for unit, electrolysis, battery-powered, ophthalmic. It is a Class I device, regulated under 21 CFR 886.4250 and reviewed by the Ophthalmic panel.
What device class is HPY?
Class I, regulation 21 CFR 886.4250. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code HPY?
Across 1 cleared submissions the average was 97 days from receipt to decision (median 97).
Which companies have the most HPY clearances?
Teknar, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code HPY
- Run a recall and safety report across every HPY manufacturer
- Watch product code HPY 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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