miraDry System

510(k) Number

K180396 ↗

FDA product code

NEY

Device class

Class II

Regulation

21 CFR Part 878.4400

Advisory committee

General, Plastic Surgery

FDA decision

SESE Substantially Equivalent

Clearances this device's FDA summary refers to, and clearances whose summaries refer to it: a citation, not a claim of equivalence.

Source: 510k-lineage (choiben314), CC BY 4.0

Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.

Other devices filed under FDA product code NEY (System, Ablation, Microwave And Accessories).

• Valleylab Microwave Ablation Generator by Covidien Lp, Formerly Know AS Valleylab, A Divison
• Microsurgeon Microwave Tissue Ablation Device, Model MTAD-200 by Microsurgeon, Inc.
• NeuWave Microwave Ablation System and Accessories by NeuWave Medical, Inc.
• Afx Microwave Generator, Flex Ablation Wand, Lynx Ablation Wand, Model Series 1000, P/N 102006, P/N 102007 by Afx, Inc.
• AveCure Microwave Coagulation-Ablation Generator, AveCure Microwave Large Antenna-Probe, AveCure Microwave Medium Antenna-Probe, AveCure Microwave Small Antenna-Probe, AveCure Microwave Mini Antenna-Probe by Medwaves Incorporated
• Certus 140 Microwave Ablation System And Accessories, Model Certus 140 by NeuWave Medical, Inc.
• Avecure 14-20-LH-35 by Medwaves Incorporated
• Emprint CART1 by Covidien LP
• Emprint SX Ablation Platform with Thermosphere Technology by Covidien llc
• Emprint Ablation System by Covidien llc

• Miradry System

  Class II

  FDA 510(k) K103014 Active Cleared 28 Jan 2011

• Dermatologic Treatment System (Dts) G2

  Class II

  FDA 510(k) K082819 Active Cleared 20 Mar 2009

• miraDry System MD4000

  Class II

  FDA 510(k) K150419 Active Cleared 19 Jun 2015

• Miradry System

  Class II

  FDA 510(k) K131162 Active Cleared 25 Oct 2013

See all devices from Miramar Labs, Inc. →