ClearanceBrief
Company ยท CN

Shangdong Huamei Technology Co., Ltd.

FDA 510(k) clearances and medical device recalls filed under this name, 2019 to 2023. Name variants (Inc, Corp, punctuation) are merged.

5510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)

Product codes

CodeDeviceRecords
GEXPowered Laser Surgical Instrument3
ONFPowered Light Based Non-Laser Surgical Instrument With Thermal Effect2

Latest 510(k) clearances

Decided510(k)Device and applicantCode
Apr 21, 2023K230816Intense Pulsed Light Treatment System
Shangdong Huamei Technology Co., Ltd., CN
ONF
Nov 16, 2020K202758Nd: YAG Laser Therapy Systems HM-YL900
Shangdong Huamei Technology Co., Ltd., CN
GEX
May 21, 2020K200751Photodynamic Therapy (PDT) Equipment
Shangdong Huamei Technology Co., Ltd., CN
GEX
Dec 6, 2019K192521Intense Pulsed Light Treatment System
Shangdong Huamei Technology Co., Ltd., CN
ONF
Dec 3, 2019K192528CO2 Laser Therapy System
Shangdong Huamei Technology Co., Ltd., CN
GEX

Latest recalls

DateFirm and productCodeLinked 510(k)
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