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 |