K250734
- 510(k) number
- K250734
- Device name
- OptiLUV Device
- Applicant
- Pollogen, Ltd. IL
- Product code
- PBX — Massager, Vacuum, Radio Frequency Induced Heat
- Decision date
- 2025-09-10
- Date received
- 2025-03-11
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- General, Plastic Surgery
PDFDownload 510(k) SummaryArchived here · 0.4 MB · U.S. public domain
Also available from FDA: K250734.pdf
Official FDA record: K250734
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.