Laseroptek Co L T D

FDA Filings

This page includes the latest FDA filings for Laseroptek Co L T D. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Registration(s)
Registration Number3007181527
FEI Number3007181527
NameDo Hyun Kim
Owner & OperatorLASEROPTEK CO., LTD.
Contact AddressHyundai I valley 114, 116, 117, 203 & 20 31 GALMACHI-RO 244BEON-GIL, JUNGWON-GU
SEONGNAM-SI KR-41 Gyeonggido 13212 KR
Official Correspondent
  • HONG CHU
  • 82-31-8023-5150
US Agent
Importing Logistics Registration
ImporterC. DALTON INTERNATIONAL, LLC.
Address2907 Shelter Island Drive, 105-109
San Diego, CA 92106 UNITED STATES
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration Address7816 Blue Ribbon Street
Fulton, MD 20759 US
Establishment TypeManufacture Medical Device



FDA Filings

Device
Company
DeviceDate
Laseroptek Co.,Ltd
PicoLO Body 2021-05-03
Laseroptek Co.,Ltd
PicoLO Foot Switch 2021-05-03
Laseroptek Co.,Ltd
PicoLO User Manual 2021-05-03
Laseroptek Co.,Ltd
PicoLO 1064 Handpiece 2021-05-03
Laseroptek Co.,Ltd
PicoLO Zoom Handpiece 2021-05-03
Laseroptek Co.,Ltd
PicoLO Collimator Handpiece 2021-05-03
Laseroptek Co.,Ltd
PicoLO 532 Handpiece 2021-05-03
Laseroptek Co.,Ltd
PicoLO Arm 2021-05-03
Laseroptek Co., Ltd.
PicoLO Nd: YAG Picosecond Laser System2021-04-07
Laseroptek Co.,Ltd
PicoLO User Manual 2020-11-05
Laseroptek Co.,Ltd
PALLAS User Manual 2020-11-05
Laseroptek Co.,Ltd
LOTUS III User Manual 2020-11-05
Laseroptek Co.,Ltd
HELIOS III User Manual 2020-11-05
Laseroptek Co.,Ltd
PicoLO User Manual 2020-03-16
Laseroptek Co.,Ltd
PALLAS power cable 2020-02-18
Laseroptek Co.,Ltd
PALLAS Foot Switch 2020-02-18
Laseroptek Co.,Ltd
PALLAS Service Manual 2020-02-18
Laseroptek Co.,Ltd
PALLAS Arm 2020-02-18
Laseroptek Co.,Ltd
PALLAS User Manual 2020-02-18
Laseroptek Co.,Ltd
PALLAS Handpiece 2020-02-18
Laseroptek Co.,Ltd
PALLAS body 2020-02-18
Laseroptek Co.,Ltd
HYPERION FIBER 2020-02-06
Laseroptek Co.,Ltd
HYPERION body 2020-02-06
Laseroptek Co.,Ltd
HYPERION Foot Switch 2020-02-06
Laseroptek Co.,Ltd
HYPERION Service Manual 2020-02-06
Laseroptek Co.,Ltd
HYPERION User Manual 2020-02-06
Laseroptek Co.,Ltd
HYPERION Blue Handpiece 2020-02-06
Laseroptek Co.,Ltd
HYPERION Red Handpiece 2020-02-06
Laseroptek Co.,Ltd
HYPERION Gold Handpiece 2020-02-06
Laseroptek Co.,Ltd
HYPERION Arm 2020-02-06
Laseroptek Co.,Ltd
HYPERION power cable 2020-02-06
Do Hyun Kim [LASEROPTEK CO., LTD.]
PALLAS 308/311 Solid-State UV Laser System2020-01-15
Laseroptek Co., Ltd.
PALLAS 308/311 Solid-State UV Laser System2020-01-03
Laseroptek Co.,Ltd
PicoLO Body 2019-11-21
Laseroptek Co.,Ltd
LOTUS III Body 2019-11-21
Laseroptek Co.,Ltd
PALLAS body 2019-11-21
Do Hyun Kim [LASEROPTEK CO., LTD.]
PicoLO Nd:YAG Picosecond Laser System2019-01-14
Do Hyun Kim [LASEROPTEK CO., LTD.]
Lotus III Multi-Pulsed Er: YAG Laser System2019-01-14
Laseroptek Co., Ltd.
PicoLO Nd:YAG Picosecond Laser System2019-01-04
Laseroptek Co., Ltd.
Lotus III Multi-Pulsed Er: Yag Laser System2018-12-27
Do Hyun Kim [LASEROPTEK CO., LTD.]
PALLAS 308/311 Solid-State UV Laser System2017-12-21
Laseroptek Co.Ltd
PALLAS 308/311 Solid-State UV Laser System2017-11-03
Do Hyun Kim [LASEROPTEK CO., LTD.]
Helios III Q-Switched Nd:YAG Laser System2016-08-09
LASEROPTEK CO. LTD.
Helios III2016-06-02
Do Hyun Kim [LASEROPTEK CO., LTD.]
HYPERION Long Pulsed Nd:YAG Dermatological Laser2014-06-18
Do Hyun Kim [LASEROPTEK CO., LTD.]
Helios II Q-Switched Nd:YAG Laser System2009-06-29
Do Hyun Kim [LASEROPTEK CO., LTD.]
Lotus II Pulsed Er:YAG Laser System2009-06-29
LASEROPTEK CO. LTD.
LOTUS II PULSED ER: YAG LASER SYSTEM2009-05-15
LASEROPTEK CO. LTD.
HELIOS II Q-SWITCHED ND:YAG LASER SYSTEM2009-04-28

Related Finance Registrations
U.S. Import Records [external site]
Import IDShipmentCargo DescriptionQuantity
2019012832310Pusan,South Korea -> New York/Newark Area, Newark, New JerseyFOOT SWITCH HANDPIECE AND ETC9018901 PKG

© 2021 FDA.report
This site is not affiliated with or endorsed by the FDA.