Instrument For Treatment Of Hyperhidrosis

Device Code: 5826

Product Code(s): OUB

Definition: Soft-tissue Coagulation

Device Classification Information

Device Type ID5826
Device NameInstrument For Treatment Of Hyperhidrosis
Physical StateThe System Consists Of The Following Components: The Console; The Handpiece; And A Disposable Tip That Snaps Onto The Handpiece.
Technical MethodMicrowave Based System
Target AreaDermal-hypodermal Interface
Regulation DescriptionElectrosurgical Cutting And Coagulation Device And Accessories.
Regulation Medical SpecialtyGeneral & Plastic Surgery
Review PanelGeneral & Plastic Surgery
Premarket Review Office Of Device Evaluation (ODE)
Division Of Surgical Devices (DSD)
General Surgery Devices Branch Two - Surgical (GSDB2)
Submission Type510(k)
CFR Regulation Number878.4400 [🔎]
FDA Device ClassificationClass 2 Medical Device
Product CodeOUB
GMP ExemptNo
Summary MREligible
Implanted DeviceNo
Life Support DeviceNo
Third Party Review Not Third Party Eligible

Recognized Standards

Total Product Life Cycle

Device Type ID5826
DeviceInstrument For Treatment Of Hyperhidrosis
Product CodeOUB
FDA Device ClassificationClass 2 Medical Device
Regulation DescriptionElectrosurgical Cutting And Coagulation Device And Accessories.
CFR Regulation Number878.4400 [🔎]
Premarket Reviews
ManufacturerDecision
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
TPLC Last Update: 2019-04-02 21:13:01

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