FDA product code MXG: Lamp, Uvc, (For Treating Skin And Wounds)
MXG is the FDA product code for lamp, uvc, (for treating skin and wounds). It is a Class II device, regulated under 21 CFR 878.4630 and reviewed by the General and Plastic Surgery panel. FDA has cleared 1 510(k) submission under MXG. The average 510(k) review took 508 days (median 508). FDA has posted 1 recall for MXG devices.
Classification
| Field | Value |
|---|---|
| Device name | Lamp, Uvc, (For Treating Skin And Wounds) |
| 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 MXG clearance
Top MXG applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Medfaxx, Inc. | 1 | 1999-02-26 |
Most recent MXG clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K973865 | Medfaxx, Inc. | BIRTCHER UV LAMP | 1999-02-26 | 508 |
Recalls for MXG devices
1 product recalls in 1 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2010-05-13.
Frequently asked questions
What is FDA product code MXG?
MXG is the FDA product code for lamp, uvc, (for treating skin and wounds). 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 MXG?
Class II, regulation 21 CFR 878.4630. Typical premarket route: 510(k).
How long does a 510(k) take for product code MXG?
Across 1 cleared submissions the average was 508 days from receipt to decision (median 508).
Which companies have the most MXG clearances?
Medfaxx, Inc. (1).
Have MXG devices been recalled?
Yes: 1 product recalls across 1 recall events; the most recent began 2010-05-13.
Next steps
- Run an FDA pathway report with predicate devices for product code MXG
- Run a recall and safety report across every MXG manufacturer
- Watch product code MXG 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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