FDA product code HLX: Photostimulator, Ac-Powered
HLX is the FDA product code for photostimulator, ac-powered. It is a Class II device, regulated under 21 CFR 886.1630 and reviewed by the Ophthalmic panel. FDA has cleared 18 510(k) submissions under HLX, from 13 different applicants. The average 510(k) review took 104 days (median 88).
Classification
| Field | Value |
|---|---|
| Device name | Photostimulator, Ac-Powered |
| Device class | Class II |
| Regulation | 21 CFR 886.1630 |
| Review panel | OP — Ophthalmic |
| Medical specialty | Ophthalmic |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
Compare with all 510(k) review times · Search every HLX clearance
Top HLX applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Life-Tech Intl., Inc. | 4 | 1982-12-28 |
| Electro-Diagnostic Imaging, Inc. | 2 | 2001-05-04 |
| Cadwell Laboratories, Inc. | 2 | 1983-05-16 |
| Clarus Medical Systems, Inc. | 1 | 1993-08-24 |
| Retina Tester | 1 | 1992-03-02 |
8 more applicants have HLX clearances. See the full list in Caduvo.
Most recent HLX clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K003442 | Electro-Diagnostic Imaging, Inc. | MODIFICATION TO EDI VERIS SYSTEM | 2001-05-04 | 179 |
| K983983 | Electro-Diagnostic Imaging, Inc. | EDI VERIS SYSTEM | 1999-02-03 | 86 |
| K925741 | Clarus Medical Systems, Inc. | CLARUS ENDOSCOPIC HOOK KNIFE | 1993-08-24 | 284 |
| K914393 | Retina Tester | RETINA TESTER | 1992-03-02 | 153 |
| K914163 | Lkc Technologies, Inc. | SCOPTOPIC SENSITIVITY TEST-1[SST-1] | 1991-10-25 | 38 |
Recalls for HLX devices
openFDA lists no recalls for product code HLX.
Frequently asked questions
What is FDA product code HLX?
HLX is the FDA product code for photostimulator, ac-powered. It is a Class II device, regulated under 21 CFR 886.1630 and reviewed by the Ophthalmic panel.
What device class is HLX?
Class II, regulation 21 CFR 886.1630. Typical premarket route: 510(k).
How long does a 510(k) take for product code HLX?
Across 18 cleared submissions the average was 104 days from receipt to decision (median 88).
Which companies have the most HLX clearances?
Life-Tech Intl., Inc. (4); Electro-Diagnostic Imaging, Inc. (2); Cadwell Laboratories, Inc. (2); Clarus Medical Systems, Inc. (1); Retina Tester (1).
Next steps
- Run an FDA pathway report with predicate devices for product code HLX
- Run a recall and safety report across every HLX manufacturer
- Watch product code HLX 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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