FDA product code HKB: Telescope, Hand-Held, Low-Vision
HKB is the FDA product code for telescope, hand-held, low-vision. It is a Class I device, regulated under 21 CFR 886.5870 and reviewed by the Ophthalmic panel. Devices under HKB reach the market by 510(k) exempt; FDA lists no cleared 510(k)s for it.
Classification
| Field | Value |
|---|---|
| Device name | Telescope, Hand-Held, Low-Vision |
| Device class | Class I |
| Regulation | 21 CFR 886.5870 |
| Review panel | OP — Ophthalmic |
| Medical specialty | Ophthalmic |
| Premarket route | 510(k) exempt |
| GMP exempt | Yes |
Recalls for HKB devices
openFDA lists no recalls for product code HKB.
Frequently asked questions
What is FDA product code HKB?
HKB is the FDA product code for telescope, hand-held, low-vision. It is a Class I device, regulated under 21 CFR 886.5870 and reviewed by the Ophthalmic panel.
What device class is HKB?
Class I, regulation 21 CFR 886.5870. Typical premarket route: 510(k) exempt.
Next steps
- Run an FDA pathway report with predicate devices for product code HKB
- Run a recall and safety report across every HKB manufacturer
- Watch product code HKB 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.