QVX · Class II · 21 CFR 878.4425

FDA Product Code QVX: Skin Patch For Treatment Of Hyperhidrosis

A Skin Patch For Treatment Of Hyperhidrosis Is A Prescription Topical Patch That Utilizes A Chemical Reaction To Generate Thermal Energy In Situ For Treatment Of Hyperhidrosis.

Leading manufacturers include Candesant Biomedical, Inc..

1
Total
0
Cleared
490d
Avg days
2023
Since
Declining activity - 0 submissions in the last 2 years vs 1 in the prior period

FDA 510(k) Cleared Skin Patch For Treatment Of Hyperhidrosis Devices (Product Code QVX)

1 devices
1–1 of 1
Not Cleared Apr 07, 2023
The N-SWEAT Patch
DEN210055
Candesant Biomedical, Inc.
General & Plastic Surgery · 490d

About Product Code QVX - Regulatory Context

510(k) Submission Activity

1 total 510(k) submissions under product code QVX since 2023, with 0 receiving FDA clearance (average review time: 490 days).

Submission volume has declined in recent years - 0 submissions in the last 24 months compared to 1 in the prior period.

QVX devices are reviewed by the General & Plastic Surgery panel. Browse all General & Plastic Surgery devices →