FDA product code HJF: Magnifier, Hand-Held, Low-Vision
HJF is the FDA product code for magnifier, hand-held, low-vision. It is a Class I device, regulated under 21 CFR 886.5540 and reviewed by the Ophthalmic panel. FDA has cleared 1 510(k) submission under HJF. The average 510(k) review took 125 days (median 125).
Classification
| Field | Value |
|---|---|
| Device name | Magnifier, Hand-Held, Low-Vision |
| Device class | Class I |
| Regulation | 21 CFR 886.5540 |
| Review panel | OP — Ophthalmic |
| Medical specialty | Ophthalmic |
| Premarket route | 510(k) exempt |
| GMP exempt | Yes |
Compare with all 510(k) review times · Search every HJF clearance
Top HJF applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Gazelle Corp. | 1 | 1982-06-14 |
Most recent HJF clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K820375 | Gazelle Corp. | PLASTIC OR GLASS MAGNIFIER | 1982-06-14 | 125 |
Recalls for HJF devices
openFDA lists no recalls for product code HJF.
Frequently asked questions
What is FDA product code HJF?
HJF is the FDA product code for magnifier, hand-held, low-vision. It is a Class I device, regulated under 21 CFR 886.5540 and reviewed by the Ophthalmic panel.
What device class is HJF?
Class I, regulation 21 CFR 886.5540. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code HJF?
Across 1 cleared submissions the average was 125 days from receipt to decision (median 125).
Which companies have the most HJF clearances?
Gazelle Corp. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code HJF
- Run a recall and safety report across every HJF manufacturer
- Watch product code HJF 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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