FDA product code HLL: Monitor, Eye Movement
HLL is the FDA product code for monitor, eye movement. It is a Class II device, regulated under 21 CFR 886.1510 and reviewed by the Ophthalmic panel. FDA has cleared 4 510(k) submissions under HLL, 1 in the last five years, from 4 different applicants. The average 510(k) review took 328 days (median 290).
Classification
| Field | Value |
|---|---|
| Device name | Monitor, Eye Movement |
| Device class | Class II |
| Regulation | 21 CFR 886.1510 |
| Review panel | OP — Ophthalmic |
| Medical specialty | Ophthalmic |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
510(k) clearances per year for HLL
| Year | Clearances | Avg. review days |
|---|---|---|
| 2023 | 1 | 265 |
Compare with all 510(k) review times · Search every HLL clearance
Top HLL applicants
| Applicant | Clearances | Latest |
|---|---|---|
| C. Light Technologies, Inc. | 1 | 2023-05-09 |
| Ober Consulting Sp. Z.O.O. | 1 | 2016-08-11 |
| Essilor Intl. | 1 | 2004-07-02 |
| Orthotone Corp. | 1 | 1988-11-16 |
Most recent HLL clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K222484 | C. Light Technologies, Inc. | Retitrack | 2023-05-09 | 265 |
| K152890 | Ober Consulting Sp. Z.O.O. | SACCADOMETER PLUS, SACCADOMETER ADVANCED | 2016-08-11 | 316 |
| K033949 | Essilor Intl. | VARILUX VISIONPRINT SYSTEM (VPS) | 2004-07-02 | 196 |
| K872111 | Orthotone Corp. | ORTHOTONE | 1988-11-16 | 534 |
Recalls for HLL devices
openFDA lists no recalls for product code HLL.
Frequently asked questions
What is FDA product code HLL?
HLL is the FDA product code for monitor, eye movement. It is a Class II device, regulated under 21 CFR 886.1510 and reviewed by the Ophthalmic panel.
What device class is HLL?
Class II, regulation 21 CFR 886.1510. Typical premarket route: 510(k).
How long does a 510(k) take for product code HLL?
Across 4 cleared submissions the average was 328 days from receipt to decision (median 290).
Which companies have the most HLL clearances?
C. Light Technologies, Inc. (1); Ober Consulting Sp. Z.O.O. (1); Essilor Intl. (1); Orthotone Corp. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code HLL
- Run a recall and safety report across every HLL manufacturer
- Watch product code HLL 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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