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Lutronic Corporation

FDA Regulatory Profile

Summary

Total Recalls
2
510(k) Clearances
29
Inspections
1
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-1558-2026Class IICLARITY II Laser System; Model No. 1110200210.January 27, 2026
Z-0146-2026Class IIXERF EFFECTOR 60. Electrosurgical unit.September 4, 2025

Recent 510(k) Clearances

K-NumberDeviceDate
K251327XERFAugust 11, 2025
K244060eCO2 3DJuly 31, 2025
K213748CoreLeveeOctober 14, 2022
K213569HOLLYWOOD SPECTRA Laser SystemFebruary 4, 2022
K203788DermaV Laser SystemMarch 26, 2021
K183566CLARITY II Laser SystemJune 14, 2019
K180945LUTRONIC GENIUS Radiofrequency SystemDecember 10, 2018
K173700PICOPLUS Laser SystemJune 19, 2018
K171009LASEMD Laser SystemJune 23, 2017
K163196ACTION II Laser SystemMay 24, 2017
K153769R:GEN Laser SystemOctober 5, 2016
K141555ADVANTAGENovember 6, 2014
K130199CLARITY LPC LASER SYSTEMNovember 22, 2013
K121481INFINI RADIOFREQUENCY SYSTEMJune 25, 2013
K113843FREEDOM ND: YAG LASER SYSTEMSeptember 27, 2012
K113668HEALITE II SYSTEMJune 19, 2012
K113502ADVANTAGE LASER SYSTEMApril 5, 2012
K113588SPECTRA LASER SYSTEMFebruary 22, 2012
K103455SPECTRA LASER SYSTEMApril 28, 2011
K100610LUTRONIC CORPORATION ECO2 PLUS, DENTA III AND III+ AND SP III LASER SYSTEMSJanuary 20, 2011