Instrument For Treatment Of Hyperhidrosis
The Instrument for Treatment of Hyperhidrosis (product code OUB) is a surgical instrument used for soft-tissue coagulation as a treatment for hyperhidrosis, a condition characterized by excessive sweating. It delivers energy to destroy sweat glands in the targeted tissue. As an FDA Class 2 device under regulation 878.4400, it requires 510(k) premarket clearance and falls within the General and Plastic Surgery specialty. The device is eligible for third-party review and is not an implant or life-sustaining device.
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Basic Information
- Product Code
- OUB
- Device Class
- FDA class 2
- Regulation Number
- 878.4400
- Medical Specialty
- General, Plastic Surgery
- Review Panel
- SU
- Submission Type
- 1
Device Characteristics
Definition
Soft-tissue coagulation
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 3 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K150419 | miraDry System MD4000 | Jun 19, 2015 | Substantially Equivalent | Miramar Labs, Inc. |
| K131162 | MIRADRY SYSTEM | Oct 25, 2013 | Substantially Equivalent | Miramar Labs, Inc. |
| K103014 | MIRADRY SYSTEM | Jan 28, 2011 | Substantially Equivalent | Miramar Labs, Inc. |
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.