FDA product code HJJ: Lens, Fresnel, Flexible, Diagnostic
HJJ is the FDA product code for lens, fresnel, flexible, diagnostic. It is a Class I device, regulated under 21 CFR 886.1390 and reviewed by the Ophthalmic panel. Devices under HJJ reach the market by 510(k) exempt; FDA lists no cleared 510(k)s for it.
Classification
| Field | Value |
|---|---|
| Device name | Lens, Fresnel, Flexible, Diagnostic |
| Device class | Class I |
| Regulation | 21 CFR 886.1390 |
| Review panel | OP — Ophthalmic |
| Medical specialty | Ophthalmic |
| Premarket route | 510(k) exempt |
| GMP exempt | Yes |
Recalls for HJJ devices
openFDA lists no recalls for product code HJJ.
Frequently asked questions
What is FDA product code HJJ?
HJJ is the FDA product code for lens, fresnel, flexible, diagnostic. It is a Class I device, regulated under 21 CFR 886.1390 and reviewed by the Ophthalmic panel.
What device class is HJJ?
Class I, regulation 21 CFR 886.1390. Typical premarket route: 510(k) exempt.
Next steps
- Run an FDA pathway report with predicate devices for product code HJJ
- Run a recall and safety report across every HJJ manufacturer
- Watch product code HJJ 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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