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Laseroptek Co., Ltd.

FDA 510(k) & PMA Approved Devices — 11 products

Total Devices11
Categories1
Latest FDA decision2025-02-07
TypeNumberDevice NameCodeDateActions
510(k) K243780 HELIOS 785 Pico (1754V2)GEX2025-02-07 View
510(k) K230373 HELIOS 785 PicoGEX2023-05-22 View
510(k) K223588 PALLAS PremiumGEX2023-01-26 View
510(k) K212663 HELIOS IV 785GEX2022-06-09 View
510(k) K212573 PicoLO PremiumGEX2021-12-08 View
510(k) K203491 PicoLO Nd: YAG Picosecond Laser SystemGEX2021-04-07 View
510(k) K191501 PALLAS 308/311 Solid-State UV Laser SystemGEX2020-01-03 View
510(k) K183392 PicoLO Nd:YAG Picosecond Laser SystemGEX2019-01-04 View
510(k) K182045 Lotus III Multi-Pulsed Er: Yag Laser SystemGEX2018-12-27 View
510(k) K172639 PALLAS 308/311 Solid-State UV Laser SystemGEX2017-11-03 View
510(k) K152856 Helios IIIGEX2016-06-02 View