DeviceClearance

Product code QVX— General, Plastic Surgery

The N-SWEAT Patch

Classification name
Skin Patch For Treatment Of Hyperhidrosis
Device class
Class 2
Regulation
21 CFR 878.4425
Advisory panel
General, Plastic Surgery
Total cleared
1
First cleared
Most recent

FDA classification definition

“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.”

— U.S. Food and Drug Administration, device classification record for product code QVX under 21 CFR 878.4425, via openFDA

Market context for product code QVX

FDA has cleared 1 device under product code QVX, all in 2023, filed by 1 applicant company. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Top applicants under product code QVX

Recent clearances under product code QVX

Data sourced from openFDA. This site is unofficial and independent of the FDA.