FDA product code HJW: Adaptometer (Biophotometer)
HJW is the FDA product code for adaptometer (biophotometer). It is a Class I device, regulated under 21 CFR 886.1050 and reviewed by the Ophthalmic panel. Devices under HJW reach the market by 510(k) exempt; FDA lists no cleared 510(k)s for it.
Classification
| Field | Value |
|---|---|
| Device name | Adaptometer (Biophotometer) |
| Device class | Class I |
| Regulation | 21 CFR 886.1050 |
| Review panel | OP — Ophthalmic |
| Medical specialty | Ophthalmic |
| Premarket route | 510(k) exempt |
Recalls for HJW devices
openFDA lists no recalls for product code HJW.
Frequently asked questions
What is FDA product code HJW?
HJW is the FDA product code for adaptometer (biophotometer). It is a Class I device, regulated under 21 CFR 886.1050 and reviewed by the Ophthalmic panel.
What device class is HJW?
Class I, regulation 21 CFR 886.1050. Typical premarket route: 510(k) exempt.
Next steps
- Run an FDA pathway report with predicate devices for product code HJW
- Run a recall and safety report across every HJW manufacturer
- Watch product code HJW 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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