FDA product code MWY: System, Microwave, Hair Removal
MWY is the FDA product code for system, microwave, hair removal. It is a Class II device, regulated under 21 CFR 878.4400 and reviewed by the General and Plastic Surgery panel. FDA has cleared 2 510(k) submissions under MWY, from 2 different applicants. The average 510(k) review took 101 days (median 101).
Classification
| Field | Value |
|---|---|
| Device name | System, Microwave, Hair Removal |
| Device class | Class II |
| Regulation | 21 CFR 878.4400 |
| Review panel | SU — General and Plastic Surgery |
| Medical specialty | General, Plastic Surgery |
| Premarket route | 510(k) |
Compare with all 510(k) review times · Search every MWY clearance
Top MWY applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Mw Medical, Inc. | 1 | 2001-03-19 |
| Microwave Medical, Inc. | 1 | 1999-10-25 |
Most recent MWY clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K010589 | Mw Medical, Inc. | MICROWAVAE DELIVERY SYSTEM #MW2000 | 2001-03-19 | 20 |
| K991456 | Microwave Medical, Inc. | MICROWAVE DELIVERY SYSTEM, MODEL MMC-300 | 1999-10-25 | 182 |
Recalls for MWY devices
openFDA lists no recalls for product code MWY.
Frequently asked questions
What is FDA product code MWY?
MWY is the FDA product code for system, microwave, hair removal. It is a Class II device, regulated under 21 CFR 878.4400 and reviewed by the General and Plastic Surgery panel.
What device class is MWY?
Class II, regulation 21 CFR 878.4400. Typical premarket route: 510(k).
How long does a 510(k) take for product code MWY?
Across 2 cleared submissions the average was 101 days from receipt to decision (median 101).
Which companies have the most MWY clearances?
Mw Medical, Inc. (1); Microwave Medical, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code MWY
- Run a recall and safety report across every MWY manufacturer
- Watch product code MWY 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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