FDA 510(k) Applications Submitted by Hae Youn Lee

FDA 510(k) Number Submission Date Device Name Applicant
K233007 09/22/2023 Picosecond Nd:YAG Laser System; PICO LEGEND AMI Inc.
K172908 09/25/2017 Q-Switched Nd:YAG Laser System AMI Inc.
K173359 10/26/2017 Fractional CO2 Surgical Laser System AMI Inc.
K231395 05/15/2023 INNO SLA Submerged Narrow Implant System Cowellmedi Co., Ltd.
K231411 05/16/2023 INNO SLA Submerged Hybrid Ti-Base System Cowellmedi Co., Ltd.
K232546 08/23/2023 Meta G UCLA Abutment Cowellmedi Co., Ltd.
K241996 07/09/2024 ULTRA 1040 ECORAY Co., Ltd.
K142813 09/29/2014 Biogensis Implant System-Kisses BIOGENESIS CO., LTD.


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