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