K251689 is an FDA 510(k) clearance for the VARIOS 170 LUX SCALER SYSTEM (VA170LUXS10). This device is classified as a Scaler, Ultrasonic (Class II - Special Controls, product code ELC).
Submitted by Nakanishi, Inc. (Kanuma, JP). The FDA issued a Cleared decision on September 19, 2025, 109 days after receiving the submission on June 2, 2025.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.4850.
| 510(k) Number | K251689 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 02, 2025 |
| Decision Date | September 19, 2025 |
| Days to Decision | 109 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | Summary PDF |
| Product Code | ELC — Scaler, Ultrasonic |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 872.4850 |