Product Code: MWY FDA class 2 21 CFR 878.4400

System, Microwave, Hair Removal

General, Plastic Surgery

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.

510(k)s
2
FEI Numbers
1
Registration Numbers
1
Unique Applicants
2
Years Active
1

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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

GMP Exempt
Implant
Life Sustain/Support
Third Party
Summary Malfunction Reporting

510(k) Clearance History

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Related 510(k) Clearances

This FDA classification is associated with 2 510(k) clearances via K numbers.

K Number Device Name
K010589 MICROWAVAE DELIVERY SYSTEM #MW2000
K991456 MICROWAVE DELIVERY SYSTEM, MODEL MMC-300

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.