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.
| Registration Number | 3007181527 | ||||
| FEI Number | 3007181527 | ||||
| Name | Do Hyun Kim | ||||
| Owner & Operator | LASEROPTEK CO., LTD. | ||||
| Contact Address | Hyundai I valley 114, 116, 117, 203 & 20 31 GALMACHI-RO 244BEON-GIL, JUNGWON-GU SEONGNAM-SI KR-41 Gyeonggido 13212 KR | ||||
| Official Correspondent |
| ||||
| US Agent |
| ||||
| Importing Logistics Registration |
| ||||
| Registration Status | 1 | ||||
| Initial Importer | N | ||||
| Registration Expiration | 2020-04-25 | ||||
| Registration Address | 7816 Blue Ribbon Street Fulton, MD 20759 US | ||||
| Establishment Type | Manufacture Medical Device |
Device Company | Device | Date |
|---|---|---|
| Laseroptek Co.,Ltd | PALLAS Premium Body | 2023-02-16 |
| Laseroptek Co.,Ltd | PALLAS Premium User Manual | 2023-02-16 |
| Laseroptek Co.,Ltd | PALLAS Premium Foot Switch | 2023-02-16 |
| Laseroptek Co.,Ltd | PALLAS Premium Handpiece - 18 x 18 | 2023-02-16 |
| Laseroptek Co.,Ltd | PALLAS Premium Handpiece - 15 x 15 | 2023-02-16 |
| Laseroptek Co.,Ltd | PALLAS Premium Handpiece - 12 x 12 | 2023-02-16 |
| Laseroptek Co.,Ltd | PALLAS Premium Arm | 2023-02-16 |
| Laseroptek Co.,Ltd | HELIOS 785 Pico Body | 2023-01-13 |
| Laseroptek Co.,Ltd | HELIOS 785 Pico User Manual | 2023-01-13 |
| Laseroptek Co.,Ltd | HELIOS 785 Pico Foot Switch | 2023-01-13 |
| Laseroptek Co.,Ltd | HELIOS 785 Pico DIA FX 785 Handpiece | 2023-01-13 |
| Laseroptek Co.,Ltd | HELIOS 785 Pico 532 FX Handpiece | 2023-01-13 |
| Laseroptek Co.,Ltd | HELIOS 785 Pico DIA FX 785 s Handpiece | 2023-01-13 |
| Laseroptek Co.,Ltd | HELIOS 785 Pico 785 Collimator Handpiece | 2023-01-13 |
| Laseroptek Co.,Ltd | HELIOS 785 Pico 785 Zoom Handpiece | 2023-01-13 |
| Laseroptek Co.,Ltd | HELIOS 785 Pico 1064 FX Handpiece | 2023-01-13 |
| Laseroptek Co.,Ltd | HELIOS 785 Pico Zoom Collimator Handpiece | 2023-01-13 |
| Laseroptek Co.,Ltd | HELIOS 785 Pico Zoom Handpiece | 2023-01-13 |
| Laseroptek Co.,Ltd | HELIOS 785 Pico Arm | 2023-01-13 |
| Laseroptek Co.,Ltd | HELIOS IV 785 Body | 2022-06-29 |
| Laseroptek Co.,Ltd | HELIOS IV 785 Arm | 2022-06-29 |
| Laseroptek Co.,Ltd | HELIOS IV 785 Body | 2022-06-29 |
| Laseroptek Co.,Ltd | HELIOS IV 785 Arm | 2022-06-29 |
| Laseroptek Co.,Ltd | HELIOS IV 785 User Manual | 2022-06-28 |
| Laseroptek Co.,Ltd | HELIOS IV 785 Foot Switch | 2022-06-28 |
| Laseroptek Co.,Ltd | HELIOS IV 785 785 CollimatorHandpiece | 2022-06-28 |
| Laseroptek Co.,Ltd | HELIOS IV 785 DIA FX 785 s Handpiece | 2022-06-28 |
| Laseroptek Co.,Ltd | HELIOS IV 785 785 Zoom Handpiece | 2022-06-28 |
| Laseroptek Co.,Ltd | HELIOS IV 785 DIA FX 785 Handpiece | 2022-06-28 |
| Laseroptek Co.,Ltd | HELIOS IV 785 532 FX Handpiece | 2022-06-28 |
| Laseroptek Co.,Ltd | HELIOS IV 785 Zoom Collimator Handpiece | 2022-06-28 |
| Laseroptek Co.,Ltd | HELIOS IV 785 1064 FX Handpiece | 2022-06-28 |
| Laseroptek Co.,Ltd | HELIOS IV 785 Zoom Handpiece | 2022-06-28 |
Laseroptek Co., Ltd. | HELIOS IV 785 | 2022-06-09 |
Laseroptek Co., Ltd. | PicoLO Premium | 2021-12-08 |
| Laseroptek Co.,Ltd | PicoLO 1064 Handpiece | 2021-08-24 |
| Laseroptek Co.,Ltd | PicoLO Power cable | 2021-08-24 |
| Laseroptek Co.,Ltd | PicoLO Foot Switch | 2021-08-24 |
| Laseroptek Co.,Ltd | PicoLO Service Manual | 2021-08-24 |
| Laseroptek Co.,Ltd | PicoLO User Manual | 2021-08-24 |
| Laseroptek Co.,Ltd | PicoLO Zoom Handpiece | 2021-08-24 |
| Laseroptek Co.,Ltd | PicoLO Collimator Handpiece | 2021-08-24 |
| Laseroptek Co.,Ltd | PicoLO 532 Handpiece | 2021-08-24 |
| Laseroptek Co.,Ltd | PicoLO 1064 Handpiece | 2021-08-24 |
| Laseroptek Co.,Ltd | PicoLO Arm | 2021-08-24 |
| 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 System | 2021-04-07 |
| 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 System | 2020-01-15 |
Laseroptek Co., Ltd. | PALLAS 308/311 Solid-State UV Laser System | 2020-01-03 |
| 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 System | 2019-01-14 |
Do Hyun Kim [LASEROPTEK CO., LTD.] | Lotus III Multi-Pulsed Er: YAG Laser System | 2019-01-14 |
Laseroptek Co., Ltd. | PicoLO Nd:YAG Picosecond Laser System | 2019-01-04 |
Laseroptek Co., Ltd. | Lotus III Multi-Pulsed Er: Yag Laser System | 2018-12-27 |
Do Hyun Kim [LASEROPTEK CO., LTD.] | PALLAS 308/311 Solid-State UV Laser System | 2017-12-21 |
Laseroptek Co.Ltd | PALLAS 308/311 Solid-State UV Laser System | 2017-11-03 |
Do Hyun Kim [LASEROPTEK CO., LTD.] | Helios III Q-Switched Nd:YAG Laser System | 2016-08-09 |
LASEROPTEK CO. LTD. | Helios III | 2016-06-02 |
Do Hyun Kim [LASEROPTEK CO., LTD.] | HYPERION Long Pulsed Nd:YAG Dermatological Laser | 2014-06-18 |
Do Hyun Kim [LASEROPTEK CO., LTD.] | Helios II Q-Switched Nd:YAG Laser System | 2009-06-29 |
Do Hyun Kim [LASEROPTEK CO., LTD.] | Lotus II Pulsed Er:YAG Laser System | 2009-06-29 |
LASEROPTEK CO. LTD. | LOTUS II PULSED ER: YAG LASER SYSTEM | 2009-05-15 |
LASEROPTEK CO. LTD. | HELIOS II Q-SWITCHED ND:YAG LASER SYSTEM | 2009-04-28 |
| Import ID | Shipment | Cargo Description | Quantity |
|---|---|---|---|
| 2019012832310 | Pusan,South Korea -> New York/Newark Area, Newark, New Jersey | FOOT SWITCH HANDPIECE AND ETC901890 | 1 PKG |