FDA product code HJS: Test, Spectacle Dissociation, Ac-Powered (Lancaster)
HJS is the FDA product code for test, spectacle dissociation, ac-powered (lancaster). It is a Class I device, regulated under 21 CFR 886.1910 and reviewed by the Ophthalmic panel. Devices under HJS reach the market by 510(k) exempt; FDA lists no cleared 510(k)s for it.
Classification
| Field | Value |
|---|---|
| Device name | Test, Spectacle Dissociation, Ac-Powered (Lancaster) |
| Device class | Class I |
| Regulation | 21 CFR 886.1910 |
| Review panel | OP — Ophthalmic |
| Medical specialty | Ophthalmic |
| Premarket route | 510(k) exempt |
Recalls for HJS devices
openFDA lists no recalls for product code HJS.
Frequently asked questions
What is FDA product code HJS?
HJS is the FDA product code for test, spectacle dissociation, ac-powered (lancaster). It is a Class I device, regulated under 21 CFR 886.1910 and reviewed by the Ophthalmic panel.
What device class is HJS?
Class I, regulation 21 CFR 886.1910. Typical premarket route: 510(k) exempt.
Next steps
- Run an FDA pathway report with predicate devices for product code HJS
- Run a recall and safety report across every HJS manufacturer
- Watch product code HJS 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.