Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

VARIOS 170 LUX SCALER SYSTEM (VA170LUXS10); VARIOS 170 LUX SCALER SYSTEM (VA170LUXS11); VARIOS 170 SCALER SYSTEM (VA170S11)

K-Number: K251689 · 2025-09-19

ApplicantNakanishi, Inc.
Decision Date2025-09-19
Product CodeELC
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

VARIOS 170 LUX SCALER SYSTEM (VA170LUXS10); VARIOS 170 LUX SCALER SYSTEM (VA170LUXS11); VARIOS 170 SCALER SYSTEM (VA170S11) is the device name listed in this FDA 510(k) record. The listed applicant is Nakanishi, Inc.. It received FDA 510(k) clearance on 2025-09-19 under 510(k) number K251689. The device is classified under product code ELC. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the VARIOS 170 LUX SCALER SYSTEM (VA170LUXS10); VARIOS 170 LUX SCALER SYSTEM (VA170LUXS11); VARIOS 170 SCALER SYSTEM (VA170S11)?

VARIOS 170 LUX SCALER SYSTEM (VA170LUXS10); VARIOS 170 LUX SCALER SYSTEM (VA170LUXS11); VARIOS 170 SCALER SYSTEM (VA170S11) is a medical device that received FDA 510(k) clearance on 2025-09-19. The listed applicant is Nakanishi, Inc.. The 510(k) number is K251689.

When did VARIOS 170 LUX SCALER SYSTEM (VA170LUXS10); VARIOS 170 LUX SCALER SYSTEM (VA170LUXS11); VARIOS 170 SCALER SYSTEM (VA170S11) receive FDA 510(k) clearance?

VARIOS 170 LUX SCALER SYSTEM (VA170LUXS10); VARIOS 170 LUX SCALER SYSTEM (VA170LUXS11); VARIOS 170 SCALER SYSTEM (VA170S11) received FDA 510(k) clearance on 2025-09-19, under 510(k) number K251689.

Who is the listed applicant for VARIOS 170 LUX SCALER SYSTEM (VA170LUXS10); VARIOS 170 LUX SCALER SYSTEM (VA170LUXS11); VARIOS 170 SCALER SYSTEM (VA170S11)?

The FDA 510(k) record lists Nakanishi, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for VARIOS 170 LUX SCALER SYSTEM (VA170LUXS10); VARIOS 170 LUX SCALER SYSTEM (VA170LUXS11); VARIOS 170 SCALER SYSTEM (VA170S11)?

The FDA product code for VARIOS 170 LUX SCALER SYSTEM (VA170LUXS10); VARIOS 170 LUX SCALER SYSTEM (VA170LUXS11); VARIOS 170 SCALER SYSTEM (VA170S11) is ELC.

Other records listing Nakanishi, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K260773Varios Combi Pro2K254163VarioSurg 4K252662UniBurK241880Air Powered Tooth Polishing System (Perio-Mate); Air Powered Tooth Polishing System (Perio Mate Nozzle Tip)K233288NLZ Built-In Motor SystemK233117Surgic Pro2 (Surgic Pro2 OPT), Surgic Pro2 (Surgic Pro2 NON-OPT)

View all 21 devices →

Related Devices (Code: ELC)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K260773Varios Combi Pro2Nakanishi, Inc.K253254GBT Machine Airflow Prophylaxis MasterE.M.S Electro Medical Systems S.AK242317Integrated Endo System (Meet Endo-II)Denjoy Dental Co., Ltd.K233844OdneCleanOdne AGK240707Ultrasonic Scaler (WD-JY-B002,WD-JY-W001,WD-JY-R003,WD-JY-G004,WD-JY-B003,WD-JY-C006,WD-JY-M0014, WD-JY-N0015,WD-JY-N0016,WD-JY-N0017,WD-JY-E007, WD-JY-F008,WD-JY-A005,WD-JY-H009,WD-JY-I0011, WD-JY-K0012,WD-JY-K0013,WD-JY-K0014, WD-JY-L0013,WD-JY-L0014,WD-JY-L0015, WD-JY-L0016,WD-JY-L0017)Shenzhen Micro Electric Intelligence Co., Ltd.K240801BioSonic US200 Ultrasonic Scaler (60034537)Dent4you AG

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

↑