FDA 510(k) Applications Submitted by Su Jin Lee
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K233120 |
09/27/2023 |
CWM-930S, FIXER DV9 |
Chungwoo Co., Ltd. |
| K100590 |
03/02/2010 |
EDGE CO2 LASER SYSTEM |
JM SYSTEM CO., LTD. |
| K240897 |
04/01/2024 |
Cellinew |
Viol Co. Ltd |
| K181896 |
07/16/2018 |
LIPOcel |
Jeisys Medical, Inc. |
| K183284 |
11/26/2018 |
INTRAcel RF Microneedle System |
Jeisys Medical Inc. |
| K230834 |
03/27/2023 |
CARDIPIA ECG / Model: CARDIPIA400H, CARDIPIA800H |
Trismed Co., Ltd. |
| K221317 |
05/06/2022 |
S-Mono |
Shinhung MST Co., Ltd. |
| K103414 |
11/22/2010 |
VENUS CERVICAL SPINAL FIXATION SYSTEM |
L&K BIOMED CO.,LTD. |
| K221752 |
06/16/2022 |
Stella |
Shinhung MST CO., LTD. |
| K223395 |
11/08/2022 |
Luna Dental Implant System |
Shinhung MST Co., Ltd |
| K211978 |
06/25/2021 |
Jplant |
JJ Medical Co., Ltd. |
| K160227 |
01/29/2016 |
ACCENTO / HWA Dual/Single laser |
BISON MEDICAL CO LTD |
| K962382 |
06/20/1996 |
XIAMEN CHINGSONG OPTICAL INDUSTRIAL CO., LTD. |
XIAMEN CHINGSONG OPTICAL INDUSTRIAL CO., LTD. |
| K150997 |
04/15/2015 |
RUBY STAR |
BISON MEDICAL CO., LTD |
| K160106 |
01/19/2016 |
LUNA DENTAL IMPLANT SYSTEM |
SHINHUNG MST Co., Ltd |
| K123155 |
10/09/2012 |
LUNA DENTAL IMPLANT SYSTEM |
SHINHUNG MST CO., LTD |
| K180729 |
03/20/2018 |
FaSet Fixation System |
Huvexel Co., Ltd |
| K162220 |
08/08/2016 |
DIO Medical IVA (ACIF, DLIF, PLIF, TLIF,and ALIF) Cage |
DIO MEDICAL CO., LTD |
| K173080 |
09/29/2017 |
IVA Cage Ti (ACIF, PLIF, TLIF, DLIF, and ALIF) |
Huvexel Co., Ltd |
| K173099 |
09/29/2017 |
Fortis and Hana Anterior Cervical Plate System |
Huvexel Co., Ltd |
| K173131 |
09/29/2017 |
Rexious Spinal Fixation System |
Huvexel Co., Ltd |
| K173201 |
10/02/2017 |
UNITY Sacroiliac Joint Fixation System |
Huvexel Co., Ltd |
| K170797 |
03/17/2017 |
wettrust D2care |
Wettrust Korea Co., Ltd. |
| K112716 |
09/19/2011 |
OSTEON II |
GENOSS CO., LTD. |
| K250582 |
02/27/2025 |
COLONNADE Posterior Screw Fixation System |
CG Bio Co., Ltd. |
| K231893 |
06/28/2023 |
LOWTEM Crystal 120 |
LowTem Co., Ltd. |
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