miraDry, Inc.
San Jose, CA, US
miraDry, Inc. appears in FDA device records in San Jose, CA. FDA records list 6 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show 2 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
FDA records under these names
1 nameFDA records resolved to miraDry, Inc. carry these names as well, as FDA wrote them. Each is the firm named on a registration, a 510(k), a PMA, a recall or an enforcement report that was joined to this company on a shared FDA identifier or on a matching name.
- Miramar Labs, Inc.510(k), enforcement report, recall
510(k) clearance history
FDA records hold 6 510(k) clearances for miraDry, Inc. between 2009 and 2018. The busiest year on record is 2009, with 1. The most recent is 2018, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2009 | 1 |
| 2011 | 1 |
| 2013 | 1 |
| 2015 | 1 |
| 2016 | 1 |
| 2018 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K180396 | miraDry System | NEY | Substantially Equivalent | |
| K160141 | miraDry System | NEY | Substantially Equivalent | |
| K150419 | miraDry System MD4000 | OUB | Substantially Equivalent | |
| K131162 | MIRADRY SYSTEM | OUB | Substantially Equivalent | |
| K103014 | MIRADRY SYSTEM | OUB | Substantially Equivalent | |
| K082819 | DERMATOLOGIC TREATMENT SYSTEM (DTS) G2 | NEY | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3008082710 | 3008082710 | miraDry, Inc. | 721 Charcot Ave, San Jose, CA 95131 US | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-0234-2016 | 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 primary axillary hyperhidrosis and was recently cleared for the permanent removal of underarm hair. | 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. | Class II | Terminated | |
| Z-2591-2011 | 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 of primary axillary hyperhidrosis. | Reports of skin burns on axilla after treatment with the miraDry System. | Terminated |
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain