miraDry, Inc.

FDA Device Registration & Listing · San Jose, CA, US · Registration 3008082710

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3008082710
FEI Number
3008082710
Entity Name
miraDry, Inc.
City/State/Country
San Jose, CA, US
Establishment Address
721 Charcot Ave, San Jose, CA 95131, US
Establishment Type(s)
Manufacture Medical Device,Complaint File Establishment per 21 CFR 820.198
Owner / Operator
miraDry Inc. (Owner Number: 10082621)
Owner / Operator Contact Address
721 Charcot Ave, San Jose, CA 95131, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K180396
PMA Number
N/A

All Registered Proprietary Names

miraDry System miraDry System miraDry System miraDry System

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
NEY System, Ablation, Microwave And Accessories General, Plastic Surgery Class 2 878.4400 2021-08-26
OUB Instrument For Treatment Of Hyperhidrosis General, Plastic Surgery Class 2 878.4400 2021-08-26
MWY System, Microwave, Hair Removal General, Plastic Surgery Class 2 878.4400 2021-08-26
NEY System, Ablation, Microwave And Accessories General, Plastic Surgery Class 2 878.4400 2021-08-26
OUB Instrument For Treatment Of Hyperhidrosis General, Plastic Surgery Class 2 878.4400 2021-08-26
NEY System, Ablation, Microwave And Accessories General, Plastic Surgery Class 2 878.4400 2021-08-26
OUB Instrument For Treatment Of Hyperhidrosis General, Plastic Surgery Class 2 878.4400 2021-08-26
MWY System, Microwave, Hair Removal General, Plastic Surgery Class 2 878.4400 2021-08-26
MWY System, Microwave, Hair Removal General, Plastic Surgery Class 2 878.4400 2021-08-26
NEY System, Ablation, Microwave And Accessories General, Plastic Surgery Class 2 878.4400 2021-08-26
OUB Instrument For Treatment Of Hyperhidrosis General, Plastic Surgery Class 2 878.4400 2021-08-26

Official Correspondent

Cynthia Kada

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

miraDry Inc.
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0210-2022 Covidien Llc 2
Covidien Emprint Ablation Catheter with Thermosphere Technology Bronchoscopic Ablation, CFN CA108L1

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3008082710. Last updated year: 2026. Please use registration number 3008082710 when referencing this establishment in official correspondence.
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