Definition: Soft-tissue Coagulation
| Device Type ID | 5826 |
| Device Name | Instrument For Treatment Of Hyperhidrosis |
| Physical State | The System Consists Of The Following Components: The Console; The Handpiece; And A Disposable Tip That Snaps Onto The Handpiece. |
| Technical Method | Microwave Based System |
| Target Area | Dermal-hypodermal Interface |
| Regulation Description | Electrosurgical Cutting And Coagulation Device And Accessories. |
| Regulation Medical Specialty | General & Plastic Surgery |
| Review Panel | General & Plastic Surgery |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Surgical Devices (DSD) General Surgery Devices Branch Two - Surgical (GSDB2) |
| Submission Type | 510(k) |
| CFR Regulation Number | 878.4400 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | OUB |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 5826 |
| Device | Instrument For Treatment Of Hyperhidrosis |
| Product Code | OUB |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Electrosurgical Cutting And Coagulation Device And Accessories. |
| CFR Regulation Number | 878.4400 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
MIRAMAR LABS, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
| Device Problems | |
|---|---|
Adverse Event Without Identified Device Or Use Problem | 293 |
Insufficient Information | 4 |
Improper Or Incorrect Procedure Or Method | 2 |
Use Of Device Problem | 1 |
Complete Blockage | 1 |
| Total Device Problems | 301 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Miramar Labs, Inc. | II | Nov-06-2015 |