510(k) · Cleared
ClearedVarios 170 Lux Scaler System (VA170LUXS10); Varios 170 Lux Scaler System (VA170LUXS11); Varios 170 Scaler System (VA170S11)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Nakanishi, Inc. · ELC Scaler, Ultrasonic
Cleared on Sep 19, 2025 as substantially equivalent to K113530 (Nakanishi, Inc., 2013) and 1 other predicate after a 109-day review. Its family tree reaches back 5 generations to 1995.
- Decided
- Sep 19, 2025
- Review
- 109 days
- Class
- Class II
- Product code
- ELC
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 5 generations to K942139 (1995). 7 ancestors in all. No later device cites it as a predicate yet.
- Root · 5 generations backK942139 Suprasson P MaxSatelec · 1995
- 4 generations backK961158 Suprasson P5 BoosterSatelec · 1996
- 3 generations backK972026 SP4044 & SP4055 Lux ModulesSatelec · 1997
- 2 generations backK033764 SP Newtron ModuleSatelec · 2004
- 1 generation backK233922 SP Newtron Can-a; Module Newtron Can-a Emb; Support Xinetic; NWT Can…Satelec - Acteon Group · 2024
- This deviceK251689 Varios 170 Lux Scaler System (VA170LUXS10); Varios 170 Lux Scaler…Nakanishi, Inc. · 2025
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K942139 | Suprasson P Max | Satelec | 1995 | — |
| −4 | K961158 | Suprasson P5 Booster | Satelec | 1996 | — |
| −3 | K972026 | SP4044 & SP4055 Lux Modules | Satelec | 1997 | — |
| −2 | K033764 | SP Newtron Module | Satelec | 2004 | — |
| −1 | K233922 | SP Newtron Can-a; Module Newtron Can-a Emb; Support Xinetic; NWT Can Slim Led… | Satelec - Acteon Group | 2024 | — |
| 0 (this device) | K251689 | Varios 170 Lux Scaler System (VA170LUXS10); Varios 170 Lux Scaler System… | Nakanishi, Inc. | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 0 |
| 2013 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in ELC? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new ELC device
- #1 K260773 Varios Combi Pro2score 12.5 · 6 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K113530 | Ultrasonic ScalerSummary page 5…21 CFR 807.92(a)(4) IK233922 SP NEWTRON CAN-A ELC I K113530 Varios 970 / Varios 970 Lux I ELC Predicate… | 2013 |
| * | K233922 | SP Newtron Can-a; Module Newtron Can-a Emb; Support Xinetic; NWT Can Slim Led Cord G3…Summary page 5…nic scaler system intended for use with an 21 CFR 807.92(a)(4) IK233922 SP NEWTRON CAN-A ELC I K113530… | 2024 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 30 years and passes through 3 companies; a new generation was cleared every 1.5 years on median.
- None of the 7 ancestors has a recall.
How does its category compare?
All ELC devicesELC Scaler, Ultrasonic: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, this device’s year, is highlighted.
FDA decisions per year · ELC
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · ELC
104in 2024
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · ELC
2in 2022
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · ELC
284in 2025
MAUDE reports naming product code ELC, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 6 | 92 | 0 | 12 |
| 2008 | 4 | 216 | 0 | 58 |
| 2009 | 4 | 121 | 0 | 108 |
| 2010 | 4 | 201 | 0 | 79 |
| 2011 | 3 | 122 | 0 | 5 |
| 2012 | 1 | — | 0 | 3 |
| 2013 | 13 | 174 | 0 | 6 |
| 2014 | 6 | 193 | 0 | 37 |
| 2015 | 5 | 150 | 0 | 135 |
| 2016 | 3 | 88 | 0 | 169 |
| 2017 | 2 | — | 0 | 356 |
| 2018 | 1 | — | 0 | 289 |
| 2019 | 4 | 192 | 0 | 302 |
| 2020 | 1 | — | 0 | 164 |
| 2021 | 3 | 196 | 0 | 166 |
| 2022 | 2 | — | 2 | 165 |
| 2023 | 5 | 258 | 0 | 210 |
| 2024 | 4 | 104 | 0 | 219 |
| 2025 | 2 | — | 0 | 284 |
| 2026 | 2 | — | 0 | — |
What is it indicated for?
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).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K251689 · printed Nov 4, 2026
Cite this page
510(k) Report. “K251689: Varios 170 Lux Scaler System (VA170LUXS10); Varios 170 Lux Scaler System (VA170LUXS11); Varios 170 Scaler System (VA170S11).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K251689
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026