# K251689: Varios 170 Lux Scaler System (VA170LUXS10); Varios 170 Lux Scaler System (VA170LUXS11); Varios 170 Scaler System (VA170S11)

- Pathway: 510(k) (Traditional)
- Applicant: Nakanishi, Inc.
- Decided: Sep 19, 2025 after 109 days
- Product code: ELC (Scaler, Ultrasonic)
- Device class: 2
- Regulation: 21 CFR 872.4850
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K942139 (1995). 7 ancestors in all.
No later device cites it as a predicate yet.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K113530: Ultrasonic Scaler, Nakanishi, Inc. (2013) Summary page 5.
- K233922: SP Newtron Can-a; Module Newtron Can-a Emb; Support Xinetic; NWT Can Slim Led Cord G3 Short; NWT Can Slim Led Cord G3 Long, Satelec - Acteon Group (2024) Summary page 5.

## Indications for use
This device, VARIOS 170 LUX SCALER SYSTEM / VARIOS 170 SCALER SYSTEM, an electronic ultrasonic scaler, is intended for use with an appropriate tip for following use: Scaling, Perio, Implant Maintenance, Endodontic, Retrograde Endo, Restorative (for Minimal Intervention/Finishing/Trimming/Polishing/Caries of Dentin), Prosthetics (Condensation/Loosening/Plugging).

Source page: https://510kreport.com/device/K251689
Methodology: https://510kreport.com/methodology