K230755
- 510(k) number
- K230755
- Device name
- NuEra Tight RF Model OptiStream
- Applicant
- Bios S.R.L. IT
- Product code
- PBX — Massager, Vacuum, Radio Frequency Induced Heat
- Decision date
- 2023-10-30
- Date received
- 2023-03-17
- 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: K230755.pdf
Official FDA record: K230755
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.