Product code QVX

Device name

Skin Patch For Treatment Of Hyperhidrosis

Medical specialty

General, Plastic Surgery

Device class

2

Regulation number

878.4425

Review panel

SU

Implant

N

Life sustaining/supporting

N

GMP exempt

N

Third party review

N

Summary malfunction reporting

Ineligible

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.

Source

FDA openFDA device classification dataset