FDA product code HLK: Screen, Tangent, Target, Battery-Powered
HLK is the FDA product code for screen, tangent, target, battery-powered. It is a Class I device, regulated under 21 CFR 886.1810 and reviewed by the Ophthalmic panel. Devices under HLK reach the market by 510(k) exempt; FDA lists no cleared 510(k)s for it.
Classification
| Field | Value |
|---|---|
| Device name | Screen, Tangent, Target, Battery-Powered |
| Device class | Class I |
| Regulation | 21 CFR 886.1810 |
| Review panel | OP — Ophthalmic |
| Medical specialty | Ophthalmic |
| Premarket route | 510(k) exempt |
| GMP exempt | Yes |
Recalls for HLK devices
openFDA lists no recalls for product code HLK.
Frequently asked questions
What is FDA product code HLK?
HLK is the FDA product code for screen, tangent, target, battery-powered. It is a Class I device, regulated under 21 CFR 886.1810 and reviewed by the Ophthalmic panel.
What device class is HLK?
Class I, regulation 21 CFR 886.1810. Typical premarket route: 510(k) exempt.
Next steps
- Run an FDA pathway report with predicate devices for product code HLK
- Run a recall and safety report across every HLK manufacturer
- Watch product code HLK 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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