510(k) K150419

Device: MiraDry System MD4000
Applicant: MIRAMAR LABS, INC.
510(k) number: K150419
Product code: OUB
Decision: Substantially Equivalent (SESE)
Decision date: 2015-06-19
Date received: 2015-02-18
Regulation: 878.4400
Classification name: Instrument For Treatment Of Hyperhidrosis
Medical specialty: General & Plastic Surgery
Review panel: General & Plastic Surgery
Device class: 2
Clearance type: Traditional
Statement or summary: Summary
Third party reviewed: No

Applicant Contact#

Contact: KATHY O'SHAUGHNESSY
Address: 2790 Walsh Ave. Santa Clara CA US 95051 95051

FDA Registration Numbers#

3008082710

Source Documents#

Other 510(k) Records For Product Code OUB #

510(k), Device, Applicant table
510(k)	Device	Applicant	Decision date
K131162	MIRADRY SYSTEM	Miramar Labs, Inc.	2013-10-25
K103014	MIRADRY SYSTEM	Miramar Labs, Inc.	2011-01-28

Legacy Summary#

summary

FDA Review#

Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases