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Sign in to claim this brandMiramar Labs, Inc.
US
Last updated May 27, 2026
Information
- Country
- US
- Address
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- Website
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- Phone
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- PRRC Contact
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- EUDAMED SRN
- —
- FDA FEI Number
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- DUNS Number
- 008226764
Catalogue (10)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| miraDry | MD4000-HP | FDA UDI | Class II | Active |
| miraDry | MD4000-BT | FDA UDI | Class II | Active |
| miraDry | MD4500-BT | FDA UDI | Class II | Active |
| miraDry | MD4000-MC | FDA UDI | Class II | Active |
| Miradry System | K103014 | FDA 510(k) | Class II | Active |
| Miradry System | K131162 | FDA 510(k) | Class II | Active |
| miraDry System | K180396 | FDA 510(k) | Class II | Active |
| miraDry System | K160141 | FDA 510(k) | Class II | Active |
| Dermatologic Treatment System (dts) G2 | K082819 | FDA 510(k) | Class II | Active |
| miraDry System MD4000 | K150419 | FDA 510(k) | Class II | Active |
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FDA Recalls (2)
Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.
| Date | Recall No. | Class | Status | Reason |
|---|---|---|---|---|
| Oct 9, 2015 | Z-0234-2016 | — | terminated | 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. |
| Apr 24, 2011 | Z-2591-2011 | — | terminated | Reports of skin burns on axilla after treatment with the miraDry System. |