510(k) Report

Devices descending from K053324

31 later devices reach Chromolite System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K082484Accelawave SystemGenesis Biosystems, Inc.200829—
+1K081578Accela SystemGenesis Biosystems, Inc.20080—
+2K093627Ipulselight Ipl System, Models HS 300C and HS 650Shanghai Apolo Medical Technologies Co., Ltd.201124—
+2K090837Stratapulse TS and StratapulseAdvanced Medical Photonics20093—
+3K200746IPL Treatment SystemsShanghai Apolo Medical Technology Co., Ltd.20205—
+3K131859Multifunctional SeriesBeijing Honkon Technologies Co., Ltd.20133—
+3K123435Ipl Therapy SystemBeijing Sincoheren S&T Development Co, Ltd.20130—
+3K122995Intense Pulsed Light (Ipl) SystemsBeijing Kes Biology Technology Co., Ltd.201316—
+3K102857Ahwon's Ipl SystemAhwon Medi Instrument Co., Ltd.20112—
+4K261204Intense Pulsed Light Therapy DeviceSanhe LEFIS Electronics Co., Ltd.20260—
+4K240474Multi-function Platform Systems (BL-M10)Shanghai Bele Medical Technology Co.,Ltd20240—
+4K231394Intense Pulsed Light SystemSmedtrum Medical Technology Co., Ltd.20232—
+4K22079410PLTentech Co., Ltd.20220—
+4K203395Platform treatment systemShanghai Apolo Medical Technology Co., Ltd.20221—
+4K192521Intense Pulsed Light Treatment SystemShangdong Huamei Technology Co., Ltd.20193—
+4K181868SHINY RPL SystemIds, Ltd.20181—
+4K161286IPL Therapy MachineBeijing Adss Development Co., Ltd.20165—
+4K150051ExiliteBTL Industries, Inc.20150—
+4K140668Platinumgmt Ipl System CloudGlobal Medical Technology S.L.20142—
+4K131712A-Tone Ipl SystemYbk Investment, Inc.20140—
+5K242440Intense Pulsed Light Treatment System (LK-PT)Nanjing Bestview Laser S&T Co., Ltd.20240—
+5K240482Intense Pulsed Light System (ST-690)Smedtrum Medical Technology Co., Ltd.20241—
+5K230816Intense Pulsed Light Treatment SystemShangdong Huamei Technology Co., Ltd.20231—
+5K220385Intense Pulsed Light EquipmentBeijing Globalipl Development Co., Ltd.20220—
+5K193328IPL + Diode Laser MachineBeijing Globalipl Development Co., Ltd.20200—
+5K192519Multi-modality workstationBeijing Superlaser Technology Co., Ltd.20192—
+5K153717Venus Versa SystemVenus Concept, Ltd.20161—
+6K251545Intense Pulsed Light Therapy Device (MMABM-1)Micowey Medical Equipment (Guangxi) Co., Ltd.20250—
+6K243123IPL Treatment Device (MDSQMC-01)Medusa (Guangxi)Medical Devices Co., Ltd.20250—
+6K232708Intense pulsed light therapy deviceHebei Zhemai Technology Co., Ltd.20230—
+6K232192Venus Versa PRO SystemVenus Concept, Inc.20230—