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Laseroptek Co., Ltd.

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
13
Inspections
0
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K243780HELIOS 785 Pico (1754V2)February 7, 2025
K230373HELIOS 785 PicoMay 22, 2023
K223588PALLAS PremiumJanuary 26, 2023
K212663HELIOS IV 785June 9, 2022
K212573PicoLO PremiumDecember 8, 2021
K203491PicoLO Nd: YAG Picosecond Laser SystemApril 7, 2021
K191501PALLAS 308/311 Solid-State UV Laser SystemJanuary 3, 2020
K183392PicoLO Nd:YAG Picosecond Laser SystemJanuary 4, 2019
K182045Lotus III Multi-Pulsed Er: Yag Laser SystemDecember 27, 2018
K172639PALLAS 308/311 Solid-State UV Laser SystemNovember 3, 2017
K152856Helios IIIJune 2, 2016
K083253LOTUS II PULSED ER: YAG LASER SYSTEMMay 15, 2009
K083203HELIOS II Q-SWITCHED ND:YAG LASER SYSTEMApril 28, 2009