K251689
- 510(k) number
- K251689
- Device name
- VARIOS 170 LUX SCALER SYSTEM (VA170LUXS10); VARIOS 170 LUX SCALER SYSTEM (VA170LUXS11); VARIOS 170 SCALER SYSTEM (VA170S11)
- Applicant
- Nakanishi, Inc. JP
- Product code
- ELC — Scaler, Ultrasonic
- Decision date
- 2025-09-19
- Date received
- 2025-06-02
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Dental
PDFDownload 510(k) SummaryArchived here · 0.9 MB · U.S. public domain
Also available from FDA: K251689.pdf
Official FDA record: K251689
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.