FDA product code HJX: Reader, Prism, Ophthalmic
HJX is the FDA product code for reader, prism, ophthalmic. It is a Class I device, regulated under 21 CFR 886.5810 and reviewed by the Ophthalmic panel. FDA has cleared 1 510(k) submission under HJX. The average 510(k) review took 20 days (median 20).
Classification
| Field | Value |
|---|---|
| Device name | Reader, Prism, Ophthalmic |
| Device class | Class I |
| Regulation | 21 CFR 886.5810 |
| Review panel | OP — Ophthalmic |
| Medical specialty | Ophthalmic |
| Premarket route | 510(k) exempt |
| GMP exempt | Yes |
Compare with all 510(k) review times · Search every HJX clearance
Top HJX applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Labtician Ophthalmics, Inc. | 1 | 2000-03-09 |
Most recent HJX clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K000544 | Labtician Ophthalmics, Inc. | BOUCHER DEGROOT HEAD POSITIONING GLASSES, MODEL 8080 | 2000-03-09 | 20 |
Recalls for HJX devices
openFDA lists no recalls for product code HJX.
Frequently asked questions
What is FDA product code HJX?
HJX is the FDA product code for reader, prism, ophthalmic. It is a Class I device, regulated under 21 CFR 886.5810 and reviewed by the Ophthalmic panel.
What device class is HJX?
Class I, regulation 21 CFR 886.5810. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code HJX?
Across 1 cleared submissions the average was 20 days from receipt to decision (median 20).
Which companies have the most HJX clearances?
Labtician Ophthalmics, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code HJX
- Run a recall and safety report across every HJX manufacturer
- Watch product code HJX 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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