System, Microwave, Hair Removal
A Microwave Hair Removal System is a device that uses microwave energy to target and destroy hair follicles by selectively heating the water in the sweat glands adjacent to follicles, providing long-term hair reduction in treated areas. It is FDA Class 2, requiring 510(k) clearance, with product code MWY under 21 CFR 878.4400 in the General and Plastic Surgery specialty. The device is not an implant and is not life-sustaining.
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Basic Information
- Product Code
- MWY
- Device Class
- FDA class 2
- Regulation Number
- 878.4400
- 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 2 510(k) clearances via K numbers.
FEI Numbers
This FDA classification entry is associated with 1 FEI number. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 1 registration number. Click on an entry to view related FDA registrations.