Lamp, Fluorescein, Ac-Powered
The AC-Powered Fluorescein Lamp is a device that emits blue light to excite fluorescein dye applied to tissue, enabling clinicians to visualize wounds, burns, or tissue viability in surgical and wound care settings. It is classified as FDA Class 2, indicating moderate risk, and requires 510(k) premarket clearance demonstrating substantial equivalence to a predicate device. The product code is HJE, regulated under 21 CFR 878.4580, within the General and Plastic Surgery medical specialty. This device is eligible for third-party 510(k) review by an FDA-accredited reviewer.
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Basic Information
- Product Code
- HJE
- Device Class
- FDA class 2
- Regulation Number
- 878.4580
- Medical Specialty
- General, Plastic Surgery
- Review Panel
- SU
- Submission Type
- 1
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 3 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K922348 | VALTRAC(R) INTRODUCER FORCEP | Jun 09, 1992 | Substantially Equivalent | American Cyanamid Co. |
| K802291 | FLUORESCENT SUN LAMP FIXTURE | Oct 31, 1980 | Substantially Equivalent | Strato-Ray Co. |
| K781698 | EXAMINER 10 | Nov 03, 1978 | Substantially Equivalent | American Sterilizer Co. |