510(k) Report

Devices descending from K060653

132 later devices reach Thermaclear through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K121435Silkn BlueHome Skinovations, Ltd.2013125—
+1K111937Clearflash AC2100 Cosmetic SystemClearflash Technologies, Inc.20120—
+1K090744CLAROClrs Technology Corporation20101—
+1K090312Tria Acne Treatment System, Model Ats-1 OtcTria Beauty, Inc.20101—
+1K080638CLAROClrs Technology Corporation20082—
+2K172555Sapphire, Elevare SapphireOmm Imports, Inc. D/B/A Zero Gravity201852—
+2K180320dpl IIa PanelLed Technologies, Inc.201814—
+2K162652Smart Photon Micro-current Device, Model: EP-300Li-Tek Electronic Technology Corporation201710—
+2K162098LED Phototherapy DeviceLi-Tek Electronic Technology Corporation201775—
+2K160821Tria SapphireTria Beauty, Inc.20160—
+2K153081Clear Bi-LightMichael Todd, LP201646—
+2K143713Lustre PRO Light SystemAmbicare Health, Ltd.20162—
+2K152889Sonilase Blue, Sonilase Blue-Clean, Sonilase Blue-UV Clean PlusBiorenew Labs, LLC20153—
+2K150282Shaser Skin Beauty Intense Pulsed Light System Family for AcneShaser, Inc.20150—
+2K131461Lightstim for Acne/ Lightstim for Acne MiniLed Intellectual Properties, LLC201481—
+3K241102Luna 4 plusForeo, Inc.20245—
+3K232656BLU TOTALE (Model: ENEOB852)Premier North America, Inc.20232—
+3K230490PMD Clean Acne, Model: 4004-CABLUE-NA, 4004-GREY-NA, 4004-YELLOW-NA, 4004-PSTO-NA…Dongguan Hunter Electronic Technology Co., Ltd.20230—
+3K231555LUMA LED patches (LUMA Blemish (TN2197) and LUMA Revive (TN2189))iSMART Developments, Ltd.20231—
+3K213039Micro-current facial cold and hot service (model: TPML-100)Li-Tek Electronics Technology C0., Ltd.20224—
+3K210545Infrared Red blue LED light heat beauty machine, Infrared Red blue LED light heat beauty…Marci Beauty, Inc.20222—
+3K210968reVive Light Therapy EssentialsLed Technologies, Inc.20213—
+3K202055Looper (Model: ZX-579S)Heat IN A Click, LLC20213—
+3K192295PDT-FaceBeijing Adss Development Co., Ltd.202046—
+3K183247dpl FacewareLed Technologies, Inc.201910—
+3K180875Poly RejuvMedtek Skincare, LLC20180—
+3K180900LED Light Therapy DeviceUvbiotek, LLC201829—
+3K180447reVive Light Therapy LED Cleansing SystemLed Technologies, Inc.201835—
+3K1718212 Face / Face EvolutionHeat IN A Click201858—
+3K170260BC-001+ Acne PurifierOriental Inspiration Limited20172—
+3K151336LightStim Professional 2-Panel LightLed Intellectual Properties, LLC20150—
+3K142246LightStim for Acne/ LightStim for Acne MiniLed Intellectual Properties, LLC201555—
+4K260767Facial Beauty Device (Facial Mask LED Beauty Device A-901; Facial LED & EMS Beauty…Kam Yuen Plastic Products, Ltd.20260—
+4K261482LightStim for Wrinkles (1984); LightStim for Acne (2038)Led Intellectual Properties, LLC20260—
+4K253833Facial & Body Beauty Device (model: INIA-BD001, INIA-BD002, INIA-BD003, INIA-BD004…Shenzhen Jianchao Intelligent Technology Co., Ltd.20260—
+4K252187Aura Glide (FC40)Aura Medical, LLC20250—
+4K252994LED Therapy Mask (SR11CM, SR11CM1, SR11CM2, SR11CM3, SR11CM4, SR11CM5, SR11CM6, SR11CM7…Guangdong Ace-Tec Co., Ltd.20250—
+4K251667LED Light Therapy Mask (M01, M02, M06, M07, M08, M09)Shenzhen Liyoutong Technology Co., Ltd.20250—
+4K250125LMNT O2Xplr, Ltd.20250—
+4K243555LED light therapy mask (E43, E32, E49B, E49C, E100B, E100C, E103B, E104B, E106A, E108A)Shenzhen Eyco Technology Co., Ltd.20250—
+4K243393JMOON NouvelleSkin Facial Toning Device (M30U PR, M30U MW, M30U SG, M30U SK, M30U MP)Shenzhen Ulike Smart Electronics Co., Ltd.20251—
+4K243423LED Light Therapy Mask (Model (s): RB-008, RB-030, RB-081, RB-008G, RB-008GB, RB-008J…Shenzhen Rainbow Technology Co., Ltd.20253—
+4K243430Micro-current Facial Beauty Device (AM-810B, AM-810W, AM-812B, AM-812W)Shenzhen Aozemei Technology Co., Ltd.20243—
+4K241718Micro-current Facial Beauty Device (AM-810B, AM-810W, AM-812B, AM-812W)Shenzhen Aozemei Technology Co., Ltd.202412—
+4K241203PMD Clean Redvolution (4005-moab-NA, 4005-moab-INT, 4005-pepper-NA, 4005-pepper-INT…Dongguan Hunter Electronic Technology Co., Ltd.20240—
+4K240132EmoLED (v. 2-USA)Emoled, Srl20240—
+4K232863Radiant Renewal Skincare Wand (HD-15, HD-15A)Shenzhen Kaiyan Medical Equipment Co., Ltd.20230—
+4K231894LED Spectrum therapy instrumentShenzhenshi Sincoheren S&T Development Co., Ltd.20230—
+4K230293TheraFace MaskTherabody, Inc.202316—
+4K230042Q-Rejuvalight Pro Facewear (Model: P19-0023)Light Tree Ventures Europe B.V.20239—
+4K223482reVive Light Therapy® Wrinkle and Acne LED DeviceLed Technologies, Inc.20222—
+4K221430reVive Light Therapy LED Cleansing SystemLed Technologies, Inc.20220—
+4K220064Synergy Marble (Model: Opasm)Yrs Group, Inc.20220—
+4K220729The Luminance RED Acne DeviceLuminance Medical Ventures, Inc.20221—
+4K212155TheraFace LEDTheragun, Inc.202142—
+4K212238TheraFace MicrocurrentTheragun, Inc.20210—
+4K203214DemarkQ WOW, DemarkQ POPShenzhen Kaiyan Medical CO, Ltd.202121—
+4K202390Aduro Light Beauty MaskShenzhen Kaiyan Medical CO, Ltd.202139—
+4K183708Poly ClearMedtek Skincare, LLC201922—
+4K183118dpl SpotLiteLed Technologies, Inc.201922—
+4K160691Acne Light Therapy WandZuko, Inc.201650—
+5K261370LED Light Therapy Masks (LED Face Mask Pulse (FAC06NA))Guangdong Newdermo Biotech Co., Ltd.20260—
+5K261496LED Light Therapy Masks (PE748, PE749, PE756)Duplex International Trading Limited20260—
+5K260895Ulike Clear Zero (YC10 BU)Guangxi Ulike Medical Technology Co., Ltd.20260—
+5K253712LED Light Therapy Mask (RB-051, RB-061, RB-071, RB-052, RB-062, RB-072, RB-053, RB-063…Shenzhen Rainbow Technology Co., Ltd.20261—
+5K253135LED Light Therapy Device (HLGMZ-3W-G1V1,HLGMZ-3W-G2V1,HLG-GJXJ-G1V1,HGMZ-2W-G1V1…Dongguan Yijiaming Technology Co., Ltd.20250—
+5K252146Multi-functional Facial Beauty Device ( SKB-1703,SKB-1803,SKB-1909, SKB-2003…Shenzhen Siken 3D Technology Development Co., Ltd.20251—
+5K252983Wrinkle Retreat Pro Light Therapy Face Mask (Model: PH-m03)Shenzhen Goodwind Technology Development Co., Ltd.20250—
+5K252142Multi-functional Facial Beauty Device (SKB-1703,SKB-1803,SKB-1809, SKB-1909…Shenzhen Siken 3D Technology Development Co., Ltd.20250—
+5K252642Microcurrent Facial Device (CEC101, EEI101)Shenzhen Dachi Communication Co., Ltd.20250—
+5K251843Erchonia EVRLErchonia Corporation20250—
+5K251727GLAM LED Facial Mask (TB-2386F)Touchbeauty Beauty & Health (Shenzhen) Co., Ltd.20250—
+5K251588LED Light Therapy Mask (FCM902, FCM905, FCM906, FCM908, 11-001-RBMASK, FCM910)Shenzhen Fittop Health Technology Co., Ltd.20252—
+5K251871FEATHER 01 02 03 04 (Model:01)Heat IN A Click, LLC20250—
+5K251076Diode Laser Hair Removal Machine (models: T60A, T60B, T60C, T60D, T60E)Shenzhen Lifotronic Technology Co., Ltd.20250—
+5K250761KALA Therapy Wand (Model: KALA-03)Shenzhen Kaiyan Medical Equipment Co., Ltd.20251—
+5K250880Led Light Mask (A093)Foshan Guangyu Weilai Medical Equipment Co., Ltd.20250—
+5K251042Light Therapy System (M500, L6)Guangzhou Ahead Intelligent Technology Co., Ltd.20251—
+5K243587PureLift GLOWXtreem Pulse, LLC20251—
+5K243330LYMA Laser PROLyma Life, Ltd.20250—
+5K242700Radiant Renewal Skincare Lid (HD-59A, HD-59B, HD-59C, HD-59D, HD-70, HD-72, HD-72A…Shenzhen Nuon Medical Equipment Co., Ltd.20246—
+5K242796CryoGlow (FW3XXXX)Sharkninja Operating, LLC20244—
+5K241933HIGHERDOSE Red and Infrared Light Mask (MK66-L)Shenzhen Kaiyan Medical Equipment Co., Ltd.20241—
+5K240360Wrinkle Treatment Device (JM2)Shenzhen Qianyu Technology Co., Ltd.20242—
+5K223919B.Light Clear Evo and B.Light Restore EvoBemer Int AG20232—
+5K230720LUSTRE 3XPRESS Light Beauty Therapy patches, model: PR6001, PR5001Light Tree Ventures Europe B.V.202318—
+5K223544LED light therapy mask (FM-01, FM-02, FM-03)Guangdong Newdermo Biotech Co., Ltd.202339—
+5K220168Skin Care Beauty Mask (Model: MJ-06)Shenzhen Kaiyan Medical CO, Ltd.202234—
+5K212771LightStim ElipsaLed Intellectual Properties, LLC20221—
+5K210948Omnilux CLEARGlobalmed Technologies202139—
+6K261407XPREEN LED Light Therapy Masks (XPRE322, XPRE326, XPRE327, XPRE342, XPRE368, XPRE422…Dongguan Miqiang Technology Co., Ltd.20260—
+6K261473ChromixTermosalud S.L.20260—
+6K260715CurrentBody Skin LED Multi Light Therapy Mask (MK-110D)The Beauty Tech Group, Ltd.20260—
+6K260150Led Facial Mask (MJ-66DB, MK-99, MK-99A, MK-99M, MJ-66C)Nooance20260—
+6K253878LUSTRE GoGlow Advanced LED Patches (PR8001, PR9001)Shenzhen Kaiyan Medical Equipment Co., Ltd.20260—
+6K253874LED Therapy Light (COB1400, HP1800PRO)Shenzhen Hanhua Opto Co., Ltd.20260—
+6K253400LED Light Therapy Face Mask (FM60X, FM60X-B, FM60X-W, FM80-W, FM80, VAP1, FM100X…Shenzhen Saidi Light Therapy Technology Co., Ltd.20250—
+6K253054LED Light Therapy Mask (M19, M19-1, M19-2, M19-3, M19-5, M19-6)Shenzhen Xinlong Precision Plastic Mold Products Co., Ltd.20250—
+6K253073LED Light Therapy Device (SG-FSM, SG-NK, SG-CT)Sunglor Technology Co., Ltd.20251—
+6K252272ORA Method LED Gua Sha (GS-04)Shenzhen Kaiyan Medical Equipment Co., Ltd.20250—