K261582
- 510(k) number
- K261582
- Device name
- Vacuum Roller RF Slimming Device for Medical Use (PZ-FY66-01, PZ-FY66-02)
- Applicant
- Zhengzhou PZ Laser Slim Technology Co., Ltd. CN
- Product code
- NUV — Massager, Vacuum, Light Induced Heating
- Decision date
- 2026-08-28
- Date received
- 2026-05-13
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- General, Plastic Surgery
PDFDownload 510(k) SummaryArchived here · 2.8 MB · U.S. public domain
Also available from FDA: K261582.pdf
Official FDA record: K261582
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.