FDA product code SGZ: Ultraviolet Lamp Products
SGZ is the FDA product code for ultraviolet lamp products. It is a Class II device, regulated under 21 CFR 878.4635 and reviewed by the General and Plastic Surgery panel. FDA has cleared 1 510(k) submission under SGZ, 1 in the last five years. The average 510(k) review took 122 days (median 122); 122 days on average over the last three years.
Definition
An ultraviolet lamp product intended to stimulate the production of Vitamin D
Classification
| Field | Value |
|---|---|
| Device name | Ultraviolet Lamp Products |
| Device class | Class II |
| Regulation | 21 CFR 878.4635 |
| Review panel | SU — General and Plastic Surgery |
| Medical specialty | General, Plastic Surgery |
| Premarket route | 510(k) |
510(k) clearances per year for SGZ
| Year | Clearances | Avg. review days |
|---|---|---|
| 2026 | 1 | 122 |
Compare with all 510(k) review times · Search every SGZ clearance
Top SGZ applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Solius Labs, Inc. | 1 | 2026-01-16 |
Most recent SGZ clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K252960 | Solius Labs, Inc. | SOLIUS PRO UVB Light Panel | 2026-01-16 | 122 |
Recalls for SGZ devices
openFDA lists no recalls for product code SGZ.
Frequently asked questions
What is FDA product code SGZ?
SGZ is the FDA product code for ultraviolet lamp products. It is a Class II device, regulated under 21 CFR 878.4635 and reviewed by the General and Plastic Surgery panel.
What device class is SGZ?
Class II, regulation 21 CFR 878.4635. Typical premarket route: 510(k).
How long does a 510(k) take for product code SGZ?
Across 1 cleared submissions the average was 122 days from receipt to decision (median 122).
Which companies have the most SGZ clearances?
Solius Labs, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code SGZ
- Run a recall and safety report across every SGZ manufacturer
- Watch product code SGZ 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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