FDA product code HPP: Headlamp, Operating, Battery-Operated
HPP is the FDA product code for headlamp, operating, battery-operated. It is a Class I device, regulated under 21 CFR 886.4335 and reviewed by the Ophthalmic panel. Devices under HPP reach the market by 510(k) exempt; FDA lists no cleared 510(k)s for it. FDA has posted 1 recall for HPP devices.
Classification
| Field | Value |
|---|---|
| Device name | Headlamp, Operating, Battery-Operated |
| Device class | Class I |
| Regulation | 21 CFR 886.4335 |
| Review panel | OP — Ophthalmic |
| Medical specialty | Ophthalmic |
| Premarket route | 510(k) exempt |
Recalls for HPP devices
1 product recalls in 1 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2014-06-11.
Frequently asked questions
What is FDA product code HPP?
HPP is the FDA product code for headlamp, operating, battery-operated. It is a Class I device, regulated under 21 CFR 886.4335 and reviewed by the Ophthalmic panel.
What device class is HPP?
Class I, regulation 21 CFR 886.4335. Typical premarket route: 510(k) exempt.
Have HPP devices been recalled?
Yes: 1 product recalls across 1 recall events; the most recent began 2014-06-11.
Next steps
- Run an FDA pathway report with predicate devices for product code HPP
- Run a recall and safety report across every HPP manufacturer
- Watch product code HPP 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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