Data / Medical devices / United States / miraDry, Inc.
miraDry, Inc.: FDA-registered device maker in San Jose, CA, United States, 1 510(k) clearance
miraDry, Inc. is registered with the FDA (registration 3008082710) in San Jose, CA, United States. It lists 3 device types. The FDA files 1 510(k) clearance under its listings, the newest dated March 15, 2018. 2 recall events name it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.
SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.
- FDA registration number
- 3008082710
- Address
- 721 Charcot Ave, San Jose, CA, United States, 95131
- Owner or operator
- miraDry Inc. (10082621)
- Roles
- Complaint file establishment, Manufacturer
- First device listed
- August 26, 2021
- Registered through
- 2026
- Brand names listed
- miraDry System
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Instrument For Treatment Of Hyperhidrosis | OUB | 2 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| System, Ablation, Microwave And Accessories | NEY | 2 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| System, Microwave, Hair Removal | MWY | 2 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| March 15, 2018 | K180396 | miraDry System | NEY | Substantially Equivalent | Miramar Labs, Inc. | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| October 9, 2015 | 72386 | Class II | Terminated | miraDry System consisting of the MD4000-MC Console, the MD4000-HP miraDry Handpiece, and the MD4000-BT miraDry bioTip and accessories. General and Plastic Surgery: The miraDry System is intended for the treatment of prim | Update to labeling for the miraDry Console to remind users to only use approved lubricants in a thin layer to prevent potential burns and blisters. | accessdata.fda.gov |
| April 24, 2011 | 58853 | Not yet classified | Terminated | MiraDry System consisting of the DTS3000 Console, MiraDry Handpiece (MD3001-HP), the miraDry biotip and the miraDry Treatment Template system. Miramar Labs, Inc. 445 Indio Way Sunnyvale, CA 94085 Intended use: Treatment | Reports of skin burns on axilla after treatment with the miraDry System. | accessdata.fda.gov |
Compare with other makers
Updated March 15, 2018. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.