FDA product code KGL: Cabinet, Phototherapy (Puva)
KGL is the FDA product code for cabinet, phototherapy (puva). It is a Class II device, regulated under 21 CFR 878.4630 and reviewed by the General and Plastic Surgery panel. FDA has cleared 8 510(k) submissions under KGL, from 6 different applicants. The average 510(k) review took 58 days (median 50).
Classification
| Field | Value |
|---|---|
| Device name | Cabinet, Phototherapy (Puva) |
| Device class | Class II |
| Regulation | 21 CFR 878.4630 |
| 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 KGL clearance
Top KGL applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Paul B. Elder Co. | 3 | 1981-03-20 |
| Sylvania Lighting Products | 1 | 1985-08-16 |
| Waldmann Lighting Co. | 1 | 1984-08-30 |
| Ultralite | 1 | 1982-03-05 |
| National Biological Corp. | 1 | 1981-04-23 |
1 more applicants have KGL clearances. See the full list in Caduvo.
Most recent KGL clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K852575 | Sylvania Lighting Products | WALDMANN F85/100W PUVA | 1985-08-16 | 59 |
| K841795 | Waldmann Lighting Co. | UV 8001K, PUVA 800, PUVA 180/200 1000 | 1984-08-30 | 120 |
| K820280 | Ultralite | SPECTRA 305/350 | 1982-03-05 | 31 |
| K810668 | National Biological Corp. | HO-B-LITE VI UNIT | 1981-04-23 | 42 |
| K810358 | Paul B. Elder Co. | PHOTOTHERAPY LIGHT CHAMBER | 1981-03-20 | 38 |
Recalls for KGL devices
openFDA lists no recalls for product code KGL.
Frequently asked questions
What is FDA product code KGL?
KGL is the FDA product code for cabinet, phototherapy (puva). It is a Class II device, regulated under 21 CFR 878.4630 and reviewed by the General and Plastic Surgery panel.
What device class is KGL?
Class II, regulation 21 CFR 878.4630. Typical premarket route: 510(k).
How long does a 510(k) take for product code KGL?
Across 8 cleared submissions the average was 58 days from receipt to decision (median 50).
Which companies have the most KGL clearances?
Paul B. Elder Co. (3); Sylvania Lighting Products (1); Waldmann Lighting Co. (1); Ultralite (1); National Biological Corp. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code KGL
- Run a recall and safety report across every KGL manufacturer
- Watch product code KGL 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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