OUB · Instrument For Treatment Of Hyperhidrosis
General, Plastic Surgery · 21 CFR 878.4400 · Class 2
Overview
| Product Code | OUB |
|---|---|
| Device Name | Instrument For Treatment Of Hyperhidrosis |
| Regulation | 21 CFR 878.4400 |
| Device Class | Class 2 |
| Review Panel | General, Plastic Surgery |
| 3rd-Party Reviewable | Yes |
Identification
An electrosurgical cutting and coagulation device and accessories is a device intended to remove tissue and control bleeding by use of high-frequency electrical current.
Classification Rationale
Class II.
Recent Cleared Devices (3 of 3)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K150419 | miraDry System MD4000 | Miramar Labs, Inc. | Jun 19, 2015 | SESE |
| K131162 | MIRADRY SYSTEM | Miramar Labs, Inc. | Oct 25, 2013 | SESE |
| K103014 | MIRADRY SYSTEM | Miramar Labs, Inc. | Jan 28, 2011 | SESE |
Top Applicants
- Miramar Labs, Inc. — 3 clearances
