FDA product code HJT: Haploscope
HJT is the FDA product code for haploscope. It is a Class I device, regulated under 21 CFR 886.1340 and reviewed by the Ophthalmic panel. FDA has cleared 2 510(k) submissions under HJT, from 2 different applicants. The average 510(k) review took 93 days (median 93).
Classification
| Field | Value |
|---|---|
| Device name | Haploscope |
| Device class | Class I |
| Regulation | 21 CFR 886.1340 |
| Review panel | OP — Ophthalmic |
| Medical specialty | Ophthalmic |
| Premarket route | 510(k) exempt |
Top HJT applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Optical Diagnostics, Inc. | 1 | 2001-12-19 |
| Neurovision, Inc. | 1 | 2001-08-31 |
Most recent HJT clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K013110 | Optical Diagnostics, Inc. | ANISEIKONIA INSPECTOR | 2001-12-19 | 161 |
| K012530 | Neurovision, Inc. | AA-1 SYSTEM | 2001-08-31 | 25 |
Recalls for HJT devices
openFDA lists no recalls for product code HJT.
Frequently asked questions
What is FDA product code HJT?
HJT is the FDA product code for haploscope. It is a Class I device, regulated under 21 CFR 886.1340 and reviewed by the Ophthalmic panel.
What device class is HJT?
Class I, regulation 21 CFR 886.1340. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code HJT?
Across 2 cleared submissions the average was 93 days from receipt to decision (median 93).
Which companies have the most HJT clearances?
Optical Diagnostics, Inc. (1); Neurovision, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code HJT
- Run a recall and safety report across every HJT manufacturer
- Watch product code HJT 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.