miraDry System MD4000
FDA 510(k) clearance K150419 · decided 2015-06-19
Clearance details
- K-number
- K150419
- Device name
- miraDry System MD4000
- Applicant
- Miramar Labs, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2015-02-18
- Decision date
- 2015-06-19
- Days to decision
- 121 days
- Clearance type
- Traditional
- Product code
- OUB
- Device class
- 2
- Regulation number
- 878.4400
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Santa Clara, CA, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| MIRADRY SYSTEM (K131162) | Miramar Labs, Inc. | 2013-10-25 |
| MIRADRY SYSTEM (K103014) | Miramar Labs, Inc. | 2011-01-28 |
Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| miraDry System consisting of the MD4000-MC Console, the MD4000-HP miraDry Handpiece, and t recall (Z-0234-2016) | Miramar Labs, Inc. | 2015-11-06 |