Skin Patch For Treatment Of Hyperhidrosis

QVX · Class II — Moderate Risk (510(k) clearance required) · General, Plastic Surgery · 21 CFR 878.4425

Classification

FDA Product Code: QVX
Device class: Class II — Moderate Risk (510(k) clearance required)
Regulation: 21 CFR 878.4425
Review panel: SU
Medical specialty: General, Plastic Surgery
Submission type: 1
GMP exempt: N
Life sustaining: N
Implant: N
Third-party review: N

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.

Market data

Cleared 510(k) submissions: 1
Registered establishments: 1

Source

Authoritative: FDA Device Classification database
Machine: JSON-LD · Markdown