FDA product code HJE: Lamp, Fluorescein, Ac-Powered
HJE is the FDA product code for lamp, fluorescein, ac-powered. It is a Class II device, regulated under 21 CFR 878.4580 and reviewed by the General and Plastic Surgery panel. FDA has cleared 3 510(k) submissions under HJE, from 3 different applicants. The average 510(k) review took 29 days (median 24).
Classification
| Field | Value |
|---|---|
| Device name | Lamp, Fluorescein, Ac-Powered |
| Device class | Class II |
| Regulation | 21 CFR 878.4580 |
| Review panel | SU — General and Plastic Surgery |
| Medical specialty | General, Plastic Surgery |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
Compare with all 510(k) review times · Search every HJE clearance
Top HJE applicants
| Applicant | Clearances | Latest |
|---|---|---|
| American Cyanamid Co. | 1 | 1992-06-09 |
| Strato-Ray Co. | 1 | 1980-10-31 |
| American Sterilizer Co. | 1 | 1978-11-03 |
Most recent HJE clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K922348 | American Cyanamid Co. | VALTRAC(R) INTRODUCER FORCEP | 1992-06-09 | 21 |
| K802291 | Strato-Ray Co. | FLUORESCENT SUN LAMP FIXTURE | 1980-10-31 | 42 |
| K781698 | American Sterilizer Co. | EXAMINER 10 | 1978-11-03 | 24 |
Recalls for HJE devices
openFDA lists no recalls for product code HJE.
Frequently asked questions
What is FDA product code HJE?
HJE is the FDA product code for lamp, fluorescein, ac-powered. It is a Class II device, regulated under 21 CFR 878.4580 and reviewed by the General and Plastic Surgery panel.
What device class is HJE?
Class II, regulation 21 CFR 878.4580. Typical premarket route: 510(k).
How long does a 510(k) take for product code HJE?
Across 3 cleared submissions the average was 29 days from receipt to decision (median 24).
Which companies have the most HJE clearances?
American Cyanamid Co. (1); Strato-Ray Co. (1); American Sterilizer Co. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code HJE
- Run a recall and safety report across every HJE manufacturer
- Watch product code HJE 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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