510(k) Report

Devices descending from K905802

1,153 later devices reach Centauri/Pegasus through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+7K251727GLAM LED Facial Mask (TB-2386F)Touchbeauty Beauty & Health (Shenzhen) Co., Ltd.20250—
+7K251588LED Light Therapy Mask (FCM902, FCM905, FCM906, FCM908, 11-001-RBMASK, FCM910)Shenzhen Fittop Health Technology Co., Ltd.20252—
+7K251076Diode Laser Hair Removal Machine (models: T60A, T60B, T60C, T60D, T60E)Shenzhen Lifotronic Technology Co., Ltd.20250—
+7K252215InbellaMAX SystemInbella Medical, Ltd.20250—
+7K250761KALA Therapy Wand (Model: KALA-03)Shenzhen Kaiyan Medical Equipment Co., Ltd.20251—
+7K243123IPL Treatment Device (MDSQMC-01)Medusa (Guangxi)Medical Devices Co., Ltd.20250—
+7K251031Fiber Laser Treatment Systems (HS-232,HS-233)Shanghai Apolo Medical Technology Co., Ltd.20250—
+7K251049SurgiLight 1470 Diode Laser System (Model:Halo)Micro-Energy Medical Technology Co., Ltd.20250—
+7K251230The Alma Hybrid Laser SystemAlma Lasers, Inc.20250—
+7K250809Stellar M22Lumenis Be, Ltd.20250—
+7K242151Radiant Renewal Skincare Wand (HD-44,HD-44A ,HD-44B,HD-44C, HD-69, HD-69A, HD-69B)Shenzhen Nuon Medical Equipment Co., Ltd.20251—
+7K250656Medical Diode Laser (Models: MZ-GK, MZ-K20, MZ-N75)Wuhan Pioon Technology Co., Ltd.20250—
+7K250125LMNT O2Xplr, Ltd.20250—
+7K244022308nm UV Phototherapy System (UV-K); 308nm UV Phototherapy System (UV-X); 308nm UV…Boston Aesthetics, Inc.20250—
+7K250113neoLaser Laser Surgery FibersG.N.S Neolaser, Ltd.20250—
+7K243488Vmat ProTermosalud20250—
+7K243141Diode Laser System (LaserPro D 980); Diode Laser System (LaserPro D 810); Diode Laser…Jiangxi Medex Technology Co., Ltd.20240—
+7K243430Micro-current Facial Beauty Device (AM-810B, AM-810W, AM-812B, AM-812W)Shenzhen Aozemei Technology Co., Ltd.20243—
+7K242440Intense Pulsed Light Treatment System (LK-PT)Nanjing Bestview Laser S&T Co., Ltd.20240—
+7K242132FreddoFabinject Lndustria E Comercio Lmportacao E Exportacao Ltda20240—
+7K241092Youlaser PRIME; Youlaser PRIME CO2; Youlaser PRIME MTQuanta System Spa20240—
+7K241102Luna 4 plusForeo, Inc.20245—
+7K240747Medical Diode Laser (M2-GK)Wuhan Pioon Technology Co., Ltd.20244—
+7K240644Medical Diode Laser (S1Pro)Wuhan Pioon Technology Co., Ltd.20242—
+7K240222Dermalux Tri-Wave MD MKII (1000021); Dermalux Compact MD (1000024)Aesthetic Technology, Ltd.20240—
+7K233344Regenalase Laser SystemIpg Medical20240—
+7K240482Intense Pulsed Light System (ST-690)Smedtrum Medical Technology Co., Ltd.20241—
+7K240132EmoLED (v. 2-USA)Emoled, Srl20240—
+7K240396Elite iQ PRO (M122K1)Cynosure, LLC20240—
+7K232885Dawn Diode Laser SystemShanghai Wonderful Opto-Electrics Tech.Co.,Ltd20240—
+7K233760Mjolnir Pro. (Multi–electrode plasma)Shenzhen Leaflife Technology Co., Ltd.20240—
+7K233143PiXel8-RevealRohrer Aesthetics20240—
+7K233224Epilaser ProEpilady 2000, LLC20240—
+7K233550MOSAIC 3D (Surgical Laser)Lutronic Aesthetic20240—
+7K232117Diode Laser Hair Removal (LHR-V6S-1064, LHR-V6S/B-1064)Wuhan Lotuxs Technology Co., Ltd.20231—
+7K232977Biophotas Celluma CONTOURBiophotas, Inc.20235—
+7K232656BLU TOTALE (Model: ENEOB852)Premier North America, Inc.20232—
+7K230490PMD Clean Acne, Model: 4004-CABLUE-NA, 4004-GREY-NA, 4004-YELLOW-NA, 4004-PSTO-NA…Dongguan Hunter Electronic Technology Co., Ltd.20230—
+7K230013Silk'n Titan AllwaysSilk'N Beauty, Ltd.20230—
+7K231054V-LaserWontech Co., Ltd.20231—
+7K231555LUMA LED patches (LUMA Blemish (TN2197) and LUMA Revive (TN2189))iSMART Developments, Ltd.20231—
+7K230720LUSTRE 3XPRESS Light Beauty Therapy patches, model: PR6001, PR5001Light Tree Ventures Europe B.V.202318—
+7K222790F65 Laser SystemLumenis Be, Ltd.20233—
+7K223147myLEDmaskMyblend20234—
+7K230816Intense Pulsed Light Treatment SystemShangdong Huamei Technology Co., Ltd.20231—
+7K221865BTL-094BTL Industries, Inc.20230—
+7K223680Eneka ProTermosalud20230—
+7K222685NIRA Model 2Dermal Photonics Corp20230—
+7K210166Omnispec ED1000Medispec, Ltd.20230—
+7K223540AvalancheLase FamilyFotona D.O.O.20230—
+7K222221Deka HelixEl.En Electronic Engineering Spa20231—
+7K223647CLEAR+BRILLIANT TOUCH® Laser SystemSolta Medical, Inc.20220—
+7K221268SR-1 Skin Treatment SystemAVAVA, Inc.20223—
+7K222701MANTA LaserSqualus Med, Ltd.20222—
+7K222915Quadruple Laser System , Models : CPMT ARES , CPMT NEMESIS , CPMT NYX PLUS , CPMT GRACE…Canadian Pioneer Medical Technology Corporation (Cpmt Laser)20220—
+7K221770Fiber Laser Treatment SystemShanghai Apolo Medical Technology Co., Ltd.20221—
+7K222064The Alma Soprano TitaniumAlma Lasers, Inc.202214—
+7K222369PURE LaserEndymed Medical, Ltd.20220—
+7K213267Dynamis Pro FamilyFotona D.O.O.20222—
+7K220531Fox 810, Fox 980A.R.C Laser GmbH20220—
+7K221189Oliz LTB-1000ALtbio Co., Ltd.20220—
+7K220385Intense Pulsed Light EquipmentBeijing Globalipl Development Co., Ltd.20220—
+7K221430reVive Light Therapy LED Cleansing SystemLed Technologies, Inc.20220—
+7K221083Smartlux MiniMedmix Co., Ltd.20222—
+7K220538DolorClast RadialE.M.S Electro Medical Systems S.A20221—
+7K220729The Luminance RED Acne DeviceLuminance Medical Ventures, Inc.20221—
+7K213332Multifrax Laser SystemParadigm Medical Corporation20220—
+7K214049Leaseir MHR XcellLeaseir Technologies, Slu202211
+7K210545Infrared Red blue LED light heat beauty machine, Infrared Red blue LED light heat beauty…Marci Beauty, Inc.20222—
+7K213350mJOULE System and AccessoriesSciton, Inc20220—
+7K210634MCL 31 Dermablate SystemAsclepion Laser Technologies GmbH20223—
+7K213534PHantom TrilogyResurgeonz, LLC20220—
+7K211722Laser treatment system , models Nyx plus, Grace plus, Nemesis, AresCanadian Pioneer Medical Technology Corporation20221—
+7K220020Cryo 7Zimmer Medizinsysteme GmbH20222—
+7K213841ENEO TOTALE (Model: ENEOT947)Premier North America, Inc.20222—
+7K210968reVive Light Therapy EssentialsLed Technologies, Inc.20213—
+7K212492Frax 1940 for Nordlys and Frax ProCandela Corporation20210—
+7K211444CellFX SystemPulse Biosciences, Inc.20213—
+7K200983Infrared light therapy led facial light therapy mask-Derma plus, Photons Facial Skin…Ningbo Hesi Electric Co., Ltd.202146—
+7K210451OrthoGold 100Tissue Regeneration Technologies, LLC20212—
+7K202258ERISE Laser handpieceEl.En Electronic Engineering Spa20210—
+7K202055Looper (Model: ZX-579S)Heat IN A Click, LLC20213—
+7K203788DermaV Laser SystemLutronic Corporation202101
+7K202985LightWalker Laser System FamilyFotona D.O.O.20217—
+7K202988Tixel SystemNovoxel, Ltd.20211—
+7K193266MIINMedico USA, Inc.20210—
+7K201594Primelase ExcellenceHigh Technology Products S.L.U20202—
+7K202028dermalux Flex MDAesthetic Technology, Ltd.20205—
+7K200971308nm Excimer SystemXuzhou Kernel Medical Equipment Co., Ltd.20201—
+7K202827308nm Excimer UV-light Skin Therapy SystemShenzhen Gsd Tech Co., Ltd.20200—
+7K202247V30 system, V20 system, V10 system, V-VR Hand pieceViora, Ltd.20200—
+7K193201BTL-785FBtl20208—
+7K201406PicowonWontech Co., Ltd.20200—
+7K201164Venus Viva MD DeviceVenus Concept USA, Inc.20203—
+7K200736Stardust MedI.T.S. Group S.R.L.20200—
+7K200786Venus EpileveVenus Concept USA, Inc.20200—
+7K200468V30 system, V20 system, V10 system, V-FC HandpieceViora, Ltd.20200—
+7K192642308nm Excimer SystemChongqing Peninsula Medical Technology Co., Ltd.20202—
+7K192295PDT-FaceBeijing Adss Development Co., Ltd.202046—
+7K200118Diode Laser Therapy DeviceShanghai Apolo Medical Technology Co., Ltd.20201—