FDA product code HLG: Pupillometer, Ac-Powered
HLG is the FDA product code for pupillometer, ac-powered. It is a Class I device, regulated under 21 CFR 886.1700 and reviewed by the Ophthalmic panel. FDA has cleared 3 510(k) submissions under HLG, from 3 different applicants. The average 510(k) review took 115 days (median 83).
Classification
| Field | Value |
|---|---|
| Device name | Pupillometer, Ac-Powered |
| Device class | Class I |
| Regulation | 21 CFR 886.1700 |
| Review panel | OP — Ophthalmic |
| Medical specialty | Ophthalmic |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every HLG clearance
Top HLG applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Trek Medical Products, Inc. | 1 | 1992-10-02 |
| Pulse Medical Instruments | 1 | 1989-11-02 |
| Minami, Tomine & Lew | 1 | 1980-12-17 |
Most recent HLG clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K920937 | Trek Medical Products, Inc. | COMPUTERIZED PUPIL | 1992-10-02 | 218 |
| K895609 | Pulse Medical Instruments | PUPIL PATHWAY ANALYZER (PPA) | 1989-11-02 | 45 |
| K802351 | Minami, Tomine & Lew | F110 PHOTO BINOCULAR OPHTHALMOSCOPE | 1980-12-17 | 83 |
Recalls for HLG devices
openFDA lists no recalls for product code HLG.
Frequently asked questions
What is FDA product code HLG?
HLG is the FDA product code for pupillometer, ac-powered. It is a Class I device, regulated under 21 CFR 886.1700 and reviewed by the Ophthalmic panel.
What device class is HLG?
Class I, regulation 21 CFR 886.1700. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code HLG?
Across 3 cleared submissions the average was 115 days from receipt to decision (median 83).
Which companies have the most HLG clearances?
Trek Medical Products, Inc. (1); Pulse Medical Instruments (1); Minami, Tomine & Lew (1).
Next steps
- Run an FDA pathway report with predicate devices for product code HLG
- Run a recall and safety report across every HLG manufacturer
- Watch product code HLG 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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