Atlas FDA

QVX

1 FDA 510(k) clearances · Product code

FDA profile

Official device name
Skin Patch For Treatment Of Hyperhidrosis
Device class
Class II (moderate risk)
Regulation
21 CFR 878.4425
Medical specialty
General, Plastic Surgery
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.
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RecordFirmDate
The N-SWEAT Patch (DEN210055)Candesant Biomedical, Inc.2023-04-07

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