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QVXClass II

Skin Patch For Treatment Of Hyperhidrosis

21 CFR 878.4425 / General, Plastic Surgery
FDA source (opens on fda.gov)

QVX is the FDA product code for Skin Patch For Treatment Of Hyperhidrosis, a class II device type, regulated under 21 CFR 878.4425. FDA's definition for this code reads: "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". As of , FDA records hold one 510(k) clearance under this code, the most recent dated , and no recalls.

Classification record

Product code
QVX
Device name
Skin Patch For Treatment Of Hyperhidrosis
FDA 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.
Regulation
21 CFR 878.4425
Device class
Class II
Review panel
General, Plastic Surgery
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
1
Ingested recalls
0

Clearances, product code QVX

By decision year
1 clearance under product code QVX with a decision year between 2023 and 2023, 2023 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code QVX by decision year
YearClearances
20231

Applicants with the most clearances

Product code QVX
Applicants holding the most 510(k) clearances under product code QVX
ApplicantClearances
Candesant Biomedical, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code

No registered establishment in MDM’s records lists product code QVX.