OUB · Class II · 21 CFR 878.4400

FDA Product Code OUB: Instrument For Treatment Of Hyperhidrosis

Soft-tissue Coagulation

Leading manufacturers include Miramar Labs, Inc..

3
Total
3
Cleared
137d
Avg days
2011
Since

FDA 510(k) Cleared Instrument For Treatment Of Hyperhidrosis Devices (Product Code OUB)

3 devices
1–3 of 3
Cleared Jun 19, 2015
miraDry System MD4000
K150419
Miramar Labs, Inc.
General & Plastic Surgery · 121d
Cleared Oct 25, 2013
MIRADRY SYSTEM
K131162
Miramar Labs, Inc.
General & Plastic Surgery · 184d
Cleared Jan 28, 2011
MIRADRY SYSTEM
K103014
Miramar Labs, Inc.
General & Plastic Surgery · 107d

About Product Code OUB - Regulatory Context