510(k) K251689

VARIOS 170 LUX SCALER SYSTEM (VA170LUXS10); VARIOS 170 LUX SCALER SYSTEM (VA170LUXS11); VARIOS 170 SCALER SYSTEM (VA170S11) by Nakanishi, Inc. — Product Code ELC

K251689 is an FDA 510(k) premarket notification submitted by Nakanishi, Inc. for the device "VARIOS 170 LUX SCALER SYSTEM (VA170LUXS10); VARIOS 170 LUX SCALER SYSTEM (VA170LUXS11); VARIOS 170 SCALER SYSTEM (VA170S11)". The FDA issued a decision of Substantially Equivalent on September 19, 2025. The device falls under product code ELC (Scaler, Ultrasonic), a Class II device regulated under 21 CFR 872.4850. Nakanishi, Inc. has at least 10 other 510(k) clearances on record.