Medical Device Manufacturer · US , Torrance , CA

Laseroptek Co., Ltd. - FDA 510(k) Cleared Devices

13 submissions · 13 cleared · Since 2009

Recent clearances: HELIOS 785 Pico (1754V2), HELIOS 785 Pico, PALLAS Premium

13
Total
13
Cleared
0
Denied

FDA 510(k) Regulatory Record - Laseroptek Co., Ltd. General & Plastic Surgery ✕

13 devices
1-12 of 13
Cleared Feb 07, 2025
HELIOS 785 Pico (1754V2)
K243780 · GEX
General & Plastic Surgery · 60d
Cleared May 22, 2023
HELIOS 785 Pico
K230373 · GEX
General & Plastic Surgery · 98d
Cleared Jan 26, 2023
PALLAS Premium
K223588 · GEX
General & Plastic Surgery · 56d
Cleared Jun 09, 2022
HELIOS IV 785
K212663 · GEX
General & Plastic Surgery · 290d
Cleared Dec 08, 2021
PicoLO Premium
K212573 · GEX
General & Plastic Surgery · 114d
Cleared Apr 07, 2021
PicoLO Nd: YAG Picosecond Laser System
K203491 · GEX
General & Plastic Surgery · 131d
Cleared Jan 03, 2020
PALLAS 308/311 Solid-State UV Laser System
K191501 · GEX
General & Plastic Surgery · 211d
Cleared Jan 04, 2019
PicoLO Nd:YAG Picosecond Laser System
K183392 · GEX
General & Plastic Surgery · 28d
Cleared Dec 27, 2018
Lotus III Multi-Pulsed Er: Yag Laser System
K182045 · GEX
General & Plastic Surgery · 150d
Cleared Nov 03, 2017
PALLAS 308/311 Solid-State UV Laser System
K172639 · GEX
General & Plastic Surgery · 63d
Cleared Jun 02, 2016
Helios III
K152856 · GEX
General & Plastic Surgery · 247d
Cleared May 15, 2009
LOTUS II PULSED ER: YAG LASER SYSTEM
K083253 · GEX
General & Plastic Surgery · 192d
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