510(k) DEN210055
DEN210055 is an FDA 510(k) premarket notification submitted by Candesant Biomedical, Inc. for the device "The N-SWEAT Patch". The FDA issued a decision of De Novo Granted on April 7, 2023. The device falls under product code QVX (Skin Patch For Treatment Of Hyperhidrosis), a Class II device regulated under 21 CFR 878.4425.
Clearance Details
- Decision
- DENG (De Novo Granted)
- Decision Date
- April 7, 2023
- Date Received
- December 3, 2021
- Clearance Type
- Direct
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Skin Patch For Treatment Of Hyperhidrosis
- Device Class
- Class II
- Regulation Number
- 878.4425
- Review Panel
- SU
- Submission Type
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.