DEN210055 is an FDA 510(k) submission for the The N-SWEAT Patch. This device is classified as a Skin Patch For Treatment Of Hyperhidrosis (Class II - Special Controls, product code QVX).
Submitted by Candesant Biomedical, Inc. (San Francisco, US). The FDA issued a Not Cleared (DENG) decision on April 7, 2023.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4425. 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..
| 510(k) Number | DEN210055 FDA.gov |
| FDA Decision | Not Cleared Not Substantially Equivalent (DENG) |
| Date Received | December 03, 2021 |
| Decision Date | April 07, 2023 |
| Days to Decision | 490 days |
| Submission Type | Direct |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | - |
| Product Code | QVX - Skin Patch For Treatment Of Hyperhidrosis |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 878.4425 |
| 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. |