miraDry System
by Miramar Labs, Inc. 4 variants
510(k) K160141
miraDry System is a medical device (FDA Class II; FDA product code NEY, System, Ablation, Microwave And Accessories) made by Miramar Labs, Inc., cleared under FDA 510(k) K160141 on 31 Oct 2016, active as of 22 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK160141 | Date31 Oct 2016 | StatusActive |
Official records
- FDA 510(k) database K160141
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- NEY
- Device class
- Class II
- Regulation
- 21 CFR Part 878.4400
- Advisory committee
- General, Plastic Surgery
- FDA decision
- SESE Substantially Equivalent
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