K243800
- 510(k) number
- K243800
- Device name
- PRO Pen Microneedling System (6883)
- Applicant
- Dermalogica, LLC CA · US
- Product code
- QAI — Powered Microneedle Device
- Decision date
- 2025-08-25
- Date received
- 2024-12-11
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- General, Plastic Surgery
PDFDownload 510(k) SummaryArchived here · 0.3 MB · U.S. public domain
Also available from FDA: K243800.pdf
Official FDA record: K243800
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.