510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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DEN210055Unknown

The N-SWEAT Patch

Candesant Biomedical, Inc., San Francisco CA / Direct, Unknown
FDA source (opens on fda.gov)

DEN210055 is the FDA 510(k) clearance record for The N-SWEAT Patch, a class II device, cleared for Candesant Biomedical, Inc. on under FDA product code QVX (Skin Patch For Treatment Of Hyperhidrosis). FDA's definition for product code QVX 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". FDA records list one 510(k) clearance for Candesant Biomedical, Inc. As of , FDA records show no recalls naming DEN210055.

Clearance record

Decision date
Received
(490 days to decision)
Product code
QVX Skin Patch For Treatment Of Hyperhidrosis
Regulation
21 CFR 878.4425
Device class
Class II
Review panel
General, Plastic Surgery
Applicant
Candesant Biomedical, Inc. 3145 Geary Blvd., San Francisco CA
Third party review
No

Clearances, product code QVX

Trailing 12 months

FDA records hold no clearances under product code QVX in the trailing twelve months.

FDA records show no clearances under product code QVX in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code QVX, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260