Laseroptek Co., Ltd. is one of 5511 FDA 510(k) medical device manufacturers from United States in the dataset, ranked by real submission volume.
Laseroptek Co., Ltd. - FDA 510(k) Cleared Devices
Recent clearances: HELIOS 785 Pico (1754V2), HELIOS 785 Pico, PALLAS Premium
13
Total
13
Cleared
0
Denied
Laseroptek Co., Ltd. has 13 FDA 510(k) cleared general & plastic surgery devices. Based in Torrance, US.
Latest FDA clearance: Feb 2025. Active since 2009.
Browse the complete list of FDA 510(k) cleared general & plastic surgery devices from this manufacturer. Filter by specialty or product code using the sidebar.
Regulatory submissions have been managed by Bt Solutions, Inc., Regulatory Technology Services, LLC and Mdr Solutions Co., Ltd..
FDA 510(k) Regulatory Record - Laseroptek Co., Ltd.
13 devices
Cleared
Feb 07, 2025
HELIOS 785 Pico (1754V2)
General & Plastic Surgery
60d
Cleared
May 22, 2023
HELIOS 785 Pico
General & Plastic Surgery
98d
Cleared
Jan 26, 2023
PALLAS Premium
General & Plastic Surgery
56d
Cleared
Jun 09, 2022
HELIOS IV 785
General & Plastic Surgery
290d
Cleared
Dec 08, 2021
PicoLO Premium
General & Plastic Surgery
114d
Cleared
Apr 07, 2021
PicoLO Nd: YAG Picosecond Laser System
General & Plastic Surgery
131d
Cleared
Jan 03, 2020
PALLAS 308/311 Solid-State UV Laser System
General & Plastic Surgery
211d
Cleared
Jan 04, 2019
PicoLO Nd:YAG Picosecond Laser System
General & Plastic Surgery
28d
Cleared
Dec 27, 2018
Lotus III Multi-Pulsed Er: Yag Laser System
General & Plastic Surgery
150d
Cleared
Nov 03, 2017
PALLAS 308/311 Solid-State UV Laser System
General & Plastic Surgery
63d
Cleared
Jun 02, 2016
Helios III
General & Plastic Surgery
247d
Cleared
May 15, 2009
LOTUS II PULSED ER: YAG LASER SYSTEM
General & Plastic Surgery
192d