510(k) Report

Devices descending from K030883

524 later devices reach Omnilux Blue through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K142372Pico Way Laser SystemCandela Corpation201470—
+6K140719Picosure WorkstationCynosure, Inc.201450—
+7K243223Multiple therapy aesthetic treatment device (BHS 202 UNYQUE)Bh Group Us, LLC20260—
+7K252723Dynamis Pro FamilyFotona D.O.O.20260—
+7K261817Diode Laser Therapy System (PZ-BDT67-01, PZ-BDT67-02)Zhengzhou PZ Laser Slim Technology Co., Ltd.20260—
+7K261851LED Light Therapy Mask (JML1, JML1+JML2); LED Light Therapy Mask (JML3, JML3+JML4); LED…Shenzhen Qianyu Technology Co., Ltd.20260—
+7K261407XPREEN LED Light Therapy Masks (XPRE322, XPRE326, XPRE327, XPRE342, XPRE368, XPRE422…Dongguan Miqiang Technology Co., Ltd.20260—
+7K253342PICO-KSpeclipse, Inc.20251—
+7K253344Bellus-QSpeclipse, Inc.20250—
+7K252308LED Beauty Mask (RLBXX)Atop Lighting Co., Ltd.20250—
+7K251632Optimas MAX SystemInMode, Ltd.20251—
+7K240983Discovery Pico; Discovery Pico Plus; Discovery Pico DermQuanta System Spa20251—
+7K251094Alma VeilWontech Co., Ltd.20250—
+7K244020Wrinkle Treatment Device (JM1, JM2B)Shenzhen Qianyu Technology Co., Ltd.20250—
+7K242382décoLITE LED DeviceiSMART Developments, Ltd.20246—
+7K241951Lasya-TrinityBLUECORE COMPANY Co., Ltd.20240—
+7K242206ActivoDaeju Meditech Engineering Co., Ltd.20240—
+7K242202LightWalker Laser System FamilyFotona D.O.O.20241—
+7K233757TitanPico Laser Workstation (PICO-450)Rhein Laser Technologies Co., Ltd.20240—
+7K231896Diode Laser Therapy SystemBeijing Adss Development Co., Ltd.20240—
+7K233090DEKA AGAIN PRO familyEl.En S.P.A.20232—
+7K230351LED Facial MaskShenzhen Sungpo Hi-Tech Electronic Co., Ltd.202333—
+7K221775LED Light Therapy Mask (model: MK-78, MK-04, MK66-H, MK66R-B, EL00003)Light Tree Ventures Europe B.V.20227—
+7K221946LED Light Therapy Mask (model: MK66R-B)Light Tree Ventures Europe B.V.202218—
+7K221427V-LaserWontech Co., Ltd.20222—
+7K221151Beauty LED Mask, Model: KFB265Hunan Guangye Biotechnology Co., Ltd.202241—
+7K212663Helios IV 785Laseroptek Co., Ltd.20223—
+7K202848S2 Pigment Removal SystemLightsense Technologies, Ltd.20210—
+7K213184MZ Skin LightMAX Supercharged LED Mask 2.0Mz Skin202135—
+7K210226PicoSure WorkstationCynosure, LLC20213—
+7K193426Elite iQCynosure, LLC20201—
+7K192583PicoLazer Laser SystemRohrer Aesthetics, LLC20200—
+7K191685PicoWay Laser SystemCandela Corporation201920—
+7K191162EpiLaze Multi-wavelength LaserRohrer Aesthetics, LLC20190—
+7K183392PicoLO Nd:YAG Picosecond Laser SystemLaseroptek Co., Ltd.20192—
+7K182997enlighten III Laser SystemCutera, Inc.20180—
+7K181486DEKA Motus AYEl.En Electronic Engineering Spa20182—
+7K181272Picocare FamilyWontech Co., Ltd.20188—
+7K173700PICOPLUS Laser SystemLutronic Corporation20187—
+7K170637sensiFirmEl Global Trade, Ltd.20173—
+7K162886Deka Motus AXEl.En Electronic Engineering Spa20171—
+7K170936Cutera enlighten III Laser SystemCutera, Inc.201710—
+7K161632FAMILY OF SQUARE EPIL (Alex, Alex2, Nd:Yag, Alex+Nd:Yag)Bios S.R.L.20161—
+7K161043Profound SystemSyneron Candela Corporation20160—
+7K161199EndyMed Contour HandpieceEndymed Medical, Ltd.20162—
+7K153568InMode Plus SystemInmode MD, Ltd.201618—
+7K160368EVO platformQuanta System Spa201636—
+7K152012EVO platformQuanta System Spa201537—
+7K151473NaturaLase PiQo4 - NaturaLase Nd:Y AG 1064 Q-switched Laser with 532 nm accessory and…Focus Medical, LLC201537—
+8K261570Picosure WorkstationCynosure, LLC20260—
+8K253309SOGA Lasers therapy system family of Aurora handpiece (Aurora-S); SOGA Lasers therapy…Shenzhen Soga Technology Co., Ltd.20260—
+8K261214Pico Shining (Pico-K; Picofy)Speclipse, Inc.20260—
+8K251981Boston PICO (Boston PICO)Boston Aesthetics, Inc.20260—
+8K252369Boston Pico755Boston Aesthetics, Inc.20260—
+8K252345Picosecond Laser Device (PF131-BI)Risu Medical Technology Co., Ltd.20250—
+8K252096Light Therapy Decollete Mask (1019135)Merchsource, LLC20250—
+8K252215InbellaMAX SystemInbella Medical, Ltd.20250—
+8K250966CurrentBody Skin™ LED Light Therapy Mask Series 2 (MK-90H)Shenzhen Kaiyan Medical Equipment Co., Ltd.20250—
+8K242996EndyMed PRO MAXEndymed Medical, Ltd.20251—
+8K242068LED Light Therapy Mask (RT01)Ningbo Dechang Electrical Machinery Made Co.,Ltd20250—
+8K243630Medical Laser System Incanto / Evoline Platinum /EvolineSolar LS Cjsc20250—
+8K243957PicoalexWontech Co., Ltd.20250—
+8K242534HandPICO Fractional Laser Handpiece TipVydence Medical20241—
+8K243040LED Light Therapy Mask…Shenzhen Siken 3D Technology Development Co., Ltd.20241—
+8K241407Splendor X (Alex, Alex2, Nd:YAG, Alex+Nd:YAG)Bios S.R.L.20240—
+8K240386Picosecond Nd:YAG Laser Systems (BL-C10)Shanghai Bele Medical Technology Co.,Ltd20240—
+8K240396Elite iQ PRO (M122K1)Cynosure, LLC20240—
+8K233114LED silicone mask (Model: LP-RVTGLWP-WHT, LP-RVTGLW-WHT, TLM200)Shenzhen Idea Light Limited20241—
+8K230373HELIOS 785 PicoLaseroptek Co., Ltd.20232—
+8K220853PicoWay Laser SystemCandela Corporation20221—
+8K214015Palm NRG cellulite body device (model: Palm NRG body device)Heat IN A Click, LLC20220—
+8K214103Shani Darden LED light therapy maskHarpar Grace International202219—
+8K212127PicocaremajestyWontech Co., Ltd.20226—
+8K201773PicohiHironic Co., Ltd.20215—
+8K211821DEKA Motus AZEl.En Electronic Engineering Spa20211—
+8K203491PicoLO Nd: YAG Picosecond Laser SystemLaseroptek Co., Ltd.20211—
+8K200116PicoSecond Nd: YAG Laser SystemShanghai Apolo Medical Technology Co., Ltd.20206—
+8K191855EmFace DeviceInmode MD, Ltd.20191—
+8K181095RF-ReliefEl Global Trade, Ltd.20181—
+8K173677InMode VLazeInmode MD, Ltd.20183—
+8K172302InMode PLUS SystemInmode MD, Ltd.201713—
+8K171711Thunder, Thunder VT, Thunder HRQuanta System Spa20170—
+8K163222Discovery Pico FamilyQuanta System Spa201630—
+9K260017Picosecond Nd:YAG Laser Systems (Model: HS-298)Shanghai Apolo Medical Technology Co., Ltd.20260—
+9K253829Medical Ultra-Pico Laser Treatment System (CM-SP-1064&532)Beijing HuaCheng Taike Technology Co., Ltd.20260—
+9K251836Dermatrix DuoShenzhen Gsd Technology Co., Ltd.20260—
+9K252753Vydence Family of LasersVydence Medical Industria E Commercio Ltda20260—
+9K252447Picosecond laser device (BMPS4)Hebei Newangie Technology Co., Ltd.20250—
+9K250734OptiLUV DevicePollogen, Ltd.20250—
+9K250041Medical Picosecond ND: YAG Laser System (PZ-6)Zhengzhou PZ Laser Slim Technology Co., Ltd.20250—
+9K243139Reverso Pro SystemIndiba S. A. U.20250—
+9K242598DEFINE System (AG612444A)InMode, Ltd.20240—
+9K241144Picosecond Nd:YAG Laser (PICOCAREMAJESTY)Wontech Co., Ltd.20241—
+9K241459MOTUS PRO FamilyEl.En S.P.A.20240—
+9K233007Picosecond Nd:YAG Laser System; PICO LEGENDAmi, Inc.20241—
+9K240752Deka ToroEl.En S.P.A.20240—
+9K240118Picosecond Nd:YAG Laser SystemSmedtrum Medical Technology Co., Ltd.20240—
+9K234104PICOANDY (Q-Switched Nd:YAG Laser)Wontech Co., Ltd.20242—
+9K233018PICOSECOND Nd:YAG Laser SystemIds, Ltd.20232—
+9K230124LUSTRE ClearSkin Renew Pro Facewear Mask (Model: PR4001)Light Tree Ventures Europe B.V.202310—