K243166
- 510(k) number
- K243166
- Device name
- Dermalage
- Applicant
- Infection Elimination Solutions, LLC SC · US
- Product code
- FRO — Dressing, Wound, Drug
- Decision date
- 2025-08-27
- Date received
- 2024-09-30
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Unknown
PDFDownload 510(k) SummaryArchived here · 2.5 MB · U.S. public domain
Also available from FDA: K243166.pdf
Official FDA record: K243166
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.