FDA.reportPublic FDA data

510(k) K231896

Device
Diode Laser Therapy System
Applicant
Beijing Adss Development Co., Ltd.
510(k) number
K231896
Product code
GEX
Decision
Substantially Equivalent (SESE)
Decision date
2024-02-20
Date received
2023-06-28
Regulation
878.4810
Classification name
Powered Laser Surgical Instrument
Medical specialty
General, Plastic Surgery
Review panel
General, Plastic Surgery
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Song Ying
Address
Rm. 609, F6, Bldg. 13, Yard 5 Tianhua St., Daxing District Beijing CN 102600 102600

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code GEX#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K261572Nd:YAG & Alexandrite Long Pulse Laser Therapy Instrument (LPDuo)Keyue (Hangzhou) Medical Information Technology Co., Ltd.2026-10-13
K262346CureLight Medical Diode Laser Systems (S3-BF45);CureLight Medical Diode Laser Systems (S2-B30);CureLight Medical Diode Laser Systems (S3-BF30);CureLight Medical Diode Laser Systems (S2-F15);CureLight Medical Diode Laser Systems (S2-H7.5)Wuhan Phomed Technology Co., Ltd.2026-10-08
K261692Diode Laser Hair Removal Machine (QDTM-03)Beijing Nubway S&T Co., Ltd.2026-10-07
K254199PicoreMax (PicoreMax)BLUECORE COMPANY Co., Ltd.2026-09-24
K241973SmartIPL_NI SystemLumenis Be, Ltd.2026-09-19
K252723Dynamis Pro FamilyFotona D.O.O.2026-09-19
K261047Dental Diode Laser Device (Laser-Pen)Guilin Kevin Peter Technology Co., Ltd.2026-09-18
K261673LED Therapy Device (QLXY-01)Beijing Nubway S&T Co., Ltd.2026-09-17
K261817Diode Laser Therapy System (PZ-BDT67-01, PZ-BDT67-02)Zhengzhou PZ Laser Slim Technology Co., Ltd.2026-09-17
K262877SOLTIVE™ Laser System (SOLTIVE™ Pro SuperPulsed Laser, SOLTIVE™ Premium SuperPulsed Laser, SOLTIVE Laser Fibers, and Accessories)Olympus Surgical Technologies America2026-09-16
K261562Diode Laser Therapy SystemSanhe LEFIS Electronics Co., Ltd.2026-09-10
K262426Medical Diode Laser (S1Pro+, S1Pro K15, S1Pro N6, S1Pro N75)Wuhan Pioon Technology Co., Ltd.2026-09-10
K2615891927nm Thulium Laser System (PZ-DJG85-01, PZ-DJG85-02)Zhengzhou PZ Laser Slim Technology Co., Ltd.2026-09-02
K262269CO2 Laser System (MBT- CO2 Laser)Beijing Mega Beauty Technology Co., Ltd.2026-09-01
K2618211565nm Laser Therapy Device (PZ-JG86-01,PZ-JG86-02)Zhengzhou PZ Laser Slim Technology Co., Ltd.2026-08-27