MIRADRY SYSTEM
FDA 510(k) clearance K103014 · decided 2011-01-28
Clearance details
- K-number
- K103014
- Device name
- MIRADRY SYSTEM
- Applicant
- Miramar Labs, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2010-10-13
- Decision date
- 2011-01-28
- Days to decision
- 107 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
- Sunnyvale, CA, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Miramar Labs
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| miraDry System MD4000 (K150419) | Miramar Labs, Inc. | 2015-06-19 |
| MIRADRY SYSTEM (K131162) | Miramar Labs, Inc. | 2013-10-25 |
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 |
| MiraDry System consisting of the DTS3000 Console, MiraDry Handpiece (MD3001-HP), the miraD recall (Z-2591-2011) | Miramar Labs, Inc. | 2011-06-17 |