510(k) Report

Devices descending from K010005

855 later devices reach Cynosure Photogenica DL through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+9K233143PiXel8-RevealRohrer Aesthetics20240—
+9K232769BeaMed Laser Surgery FibersBt Beamedical Tachnoogies Ltd. (Beamed)20231—
+9K233147PiXel8-RFRohrer Aesthetics20230—
+9K232223PlaDuo SystemShenB Co., Ltd.20230—
+9K232499IPL Hair Removal Device (LS-T106, LS-T107, LS-T108)Shenzhen Lescolton Electrical Appliance Co., Ltd.20234—
+9K232183IPL Hair Removal Device, Model (s): T1, T2, T3, T7, T10Shenzhen Koli Technology Co.,Ltd20230—
+9K231790The InMode System with the Morpheus8 ApplicatorsInMode, Ltd.202310—
+9K222790F65 Laser SystemLumenis Be, Ltd.20233—
+9K230373HELIOS 785 PicoLaseroptek Co., Ltd.20232—
+9K220322Pollogen STOP U Model UXV DevicePollogen, Ltd.20233—
+9K230819OmniGuide RFID Surgical Laser FibersOmni-Guide Holdings, Inc.20230—
+9K230097IPL Hair Removal Device, Model (s): BSXT101, BSXT102, BSXT103, BSXT105, BSXT106, BSXT108Shenzhen Bsx Technology Electronics Co., Ltd.20238—
+9K222260Capenergy C Equipment RF System - C25, C50, C100, C200, C300, C400, C500Capenergy Medical S.L.20233—
+9K222709Retraction, CWM-910T, APOLEX TiteChungwoo Co., Ltd.20230—
+9K222221Deka HelixEl.En Electronic Engineering Spa20231—
+9K222710IPL Cooling Hair Removal DeviceShenzhen Siken 3D Technology Development Co., Ltd.20220—
+9K220853PicoWay Laser SystemCandela Corporation20221—
+9K221770Fiber Laser Treatment SystemShanghai Apolo Medical Technology Co., Ltd.20221—
+9K222432IPL Hair Removal Device, Model (s): KCA423, KCA437, KCA439Hunan Guangye Biotechnology Co., Ltd.20220—
+9K222316IPL Hair Removal DeviceShenzhen Goodwind Technology Development Co., Ltd.20221—
+9K214015Palm NRG cellulite body device (model: Palm NRG body device)Heat IN A Click, LLC20220—
+9K221427V-LaserWontech Co., Ltd.20222—
+9K221466IPL Hair Removal Device, model: AI01, AI06, AI08, AI16, AI17Shenzhen Century Dongyuan Technology CO, Ltd.20220—
+9K221407truSculpt iDCutera, Inc.20222—
+9K212472AgeJetTriworks Group Srl20220—
+9K220248Home use hair removal deviceShenzhen Mareal Tech Co., Ltd.20228—
+9K211000AcutronIlooda Co,., Ltd.20220—
+9K220793InnoVoyce Laser FiberInnovoyce, LLC20220—
+9K220669IPL HAIR REMOVAL HANDSET, Model: IPL-666Shenzhen Junbobeauty Technology Co., Ltd.20222—
+9K220222IPL Hair Removal Device, model (s): S1-A, S2-A, S1, S2, S3, S4Shenzhen Yuwei Electronic Technology Co., Ltd.202213—
+9K212318IPL Hair RemovalDongguan Define Beauty Electronic Technology Co., Ltd.202226—
+9K212127PicocaremajestyWontech Co., Ltd.20226—
+9K213020IPL hair removal machineShenzhen Borria Technology Co., Ltd.20210—
+9K210350Gemini 2 810+980 Soft Tissue LaserAzena Medical, LLC20211—
+9K201773PicohiHironic Co., Ltd.20215—
+9K211821DEKA Motus AZEl.En Electronic Engineering Spa20211—
+9K202884SR-1 Skin Treatment SystemAVAVA, Inc.20214—
+9K203491PicoLO Nd: YAG Picosecond Laser SystemLaseroptek Co., Ltd.20211—
+9K201387Ultrafast, Ultrafast Plus, Ultrafast LiteDentlight, Inc.20210—
+9K202199BTL-899STBtl20216—
+9K200116PicoSecond Nd: YAG Laser SystemShanghai Apolo Medical Technology Co., Ltd.20206—
+9K191855EmFace DeviceInmode MD, Ltd.20191—
+9K190678TempSureCynosure, Inc.201914—
+9K191162EpiLaze Multi-wavelength LaserRohrer Aesthetics, LLC20190—
+9K182365TempSure SystemCynosure, Inc.201815—
+9K181095RF-ReliefEl Global Trade, Ltd.20181—
+9K173677InMode VLazeInmode MD, Ltd.20183—
+9K172302InMode PLUS SystemInmode MD, Ltd.201713—
+9K172771Epic Pro 940Biolase, Inc.20171—
+9K171711Thunder, Thunder VT, Thunder HRQuanta System Spa20170—
+9K170116Thermi Injectable RF ElectrodesThermi20172—
+9K163190InMode RF SystemInmode MD, Ltd.20160—
+9K163222Discovery Pico FamilyQuanta System Spa201630—
+9K161162Frax 1550 for Ellipse Nordlys/ Ellipse Nordlys+, Ellipse Sirius, Ellipse Infinity…Ellipse A/S20164—
+9K161403A.R.C. Laser Surgical Fibers and ProbesA.R.C Laser GmbH20160—
+9K150282Shaser Skin Beauty Intense Pulsed Light System Family for AcneShaser, Inc.20150—
+9K142924Shaser Skin Beauty SkinREJUV Intense, Pulsed Light System FamilyShaser, Inc.20150—
+10K254185Potenza PrimeJeisys Medical Incorporated20260—
+10K2618211565nm Laser Therapy Device (PZ-JG86-01,PZ-JG86-02)Zhengzhou PZ Laser Slim Technology Co., Ltd.20260—
+10K253859Scarlet Pro (Scarlet Pro)VIOL Co., Ltd.20260—
+10K253484Lutronic GeniusCynosure Lutronic Technology Corporation20260—
+10K253803MILAN SystemLumenis Be, Ltd.20260—
+10K260138LUNE PureHygieneEnamel Pure20260—
+10K260594IPL Hair Removal Device (FL-B505AG, FL-B505AP, FL-B505AM, FL-B507AG, FL-B507AP…Shenzhen Xiazhifeng Electronic Co., Ltd.20260—
+10K261214Pico Shining (Pico-K; Picofy)Speclipse, Inc.20260—
+10K260017Picosecond Nd:YAG Laser Systems (Model: HS-298)Shanghai Apolo Medical Technology Co., Ltd.20260—
+10K260765Gemini NOVA 810+980 Soft Tissue LaserAzena Medical, LLC20260—
+10K253829Medical Ultra-Pico Laser Treatment System (CM-SP-1064&532)Beijing HuaCheng Taike Technology Co., Ltd.20260—
+10K251435InbellaIgnite RF SystemInbella Medical, Inc.20260—
+10K252753Vydence Family of LasersVydence Medical Industria E Commercio Ltda20260—
+10K251254Ignite RF SystemInMode, Ltd.20260—
+10K250341Sensilift Pro (ST300XXYYZZZ)El Global Trade, Ltd.20260—
+10K252745Halo Sterile Single-use Radial Fiber…Micro-Energy Medical Technology Co., Ltd.20251—
+10K253007Laser Fiber (PT-OF-A-S); Laser Fiber (PT-OF-B-S); Laser Fiber (PT-OF-C-S); Laser Fiber…Guangzhou Potent Medical Equipment Joint-Stock Co., Ltd.20250—
+10K252367InbellaMulti SystemInbella Medical, Inc.20250—
+10K252447Picosecond laser device (BMPS4)Hebei Newangie Technology Co., Ltd.20250—
+10K251334New Doublo 2.0Hironic Co., Ltd.20250—
+10K250734OptiLUV DevicePollogen, Ltd.20250—
+10K251781Kala Mini 2.0 (Kala-04)Shenzhen Kaiyan Medical Equipment Co., Ltd.20250—
+10K251031Fiber Laser Treatment Systems (HS-232,HS-233)Shanghai Apolo Medical Technology Co., Ltd.20250—
+10K242755Medical Diode Laser Systems (VELAS II-30B, VELAS II-30A, GBOX-15AB, GBOX-20B, CHEESE…Gigaalaser Company, Ltd.20251—
+10K250041Medical Picosecond ND: YAG Laser System (PZ-6)Zhengzhou PZ Laser Slim Technology Co., Ltd.20250—
+10K242469RFMagik LiteAgnes Medical Co., Ltd.20252—
+10K250113neoLaser Laser Surgery FibersG.N.S Neolaser, Ltd.20250—
+10K242941CO2 Laser Therapy Systems (SHE-LSP003-1)Beijing Sano Laser S&T Development Co.,Ltd20250—
+10K242598DEFINE System (AG612444A)InMode, Ltd.20240—
+10K242349FoLixLumenis Be, Ltd.20240—
+10K241144Picosecond Nd:YAG Laser (PICOCAREMAJESTY)Wontech Co., Ltd.20241—
+10K241459MOTUS PRO FamilyEl.En S.P.A.20240—
+10K233007Picosecond Nd:YAG Laser System; PICO LEGENDAmi, Inc.20241—
+10K240969IPL Hair Removal (SL-B287, SL-B329, SL-B301-1, SL-B328)Shenzhen Semlamp Intelligent Technology Co., Ltd.20240—
+10K240752Deka ToroEl.En S.P.A.20240—
+10K233766Geneo X ElitePollogen, Ltd.20240—
+10K240118Picosecond Nd:YAG Laser SystemSmedtrum Medical Technology Co., Ltd.20240—
+10K233642InMode RF SystemInMode, Ltd.20244—
+10K234104PICOANDY (Q-Switched Nd:YAG Laser)Wontech Co., Ltd.20242—
+10K240264Home Use Hair Removal Device (Model (s):T10A, T10B, T10C, T10D, T11A, T15A, T17A, T18A…Shenzhen Mlay Intelligent Technology Co.,, Ltd.20246—
+10K232424CurrentBody Skin RFEl Global Trade, Ltd.20240—
+10K233018PICOSECOND Nd:YAG Laser SystemIds, Ltd.20232—
+10K232846Light Based Hair Removal DeviceShenzhen Meik Beauty Industry Co., Ltd.20230—