510(k) Report

Devices descending from K020453

1,018 later devices reach Palomar Estelux Pulsed Light System and Palomar Coolroller through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+4K070392Mosaic Laser SystemLutronic Corporation20078—
+4K071152Palomar Erbium HandpiecePalomar Medical Products, Inc.2007159—
+4K071295100W Ceralas D 980NM Diode LaserBiolitec, Inc.2007230—
+4K063715Juniper Cooling Device XtraJuniper Medical, Inc.200735—
+4K063396Velure Family of Diode Lasers and Delivery Device AccessoriesLasering S.R.L.200722—
+4K060977Medlite C Series Compression Tool and Handpiece Attachment Accessory, Model 659-0523Hoya Conbio, Inc.20060—
+5K261473ChromixTermosalud S.L.20260—
+5K261204Intense Pulsed Light Therapy DeviceSanhe LEFIS Electronics Co., Ltd.20260—
+5K260715CurrentBody Skin LED Multi Light Therapy Mask (MK-110D)The Beauty Tech Group, Ltd.20260—
+5K253245Boston 2910 (Boston 2910)Boston Aesthetics, Inc.20260—
+5K260688Sculpt LED Belt (HY-150A/HY-150B/HY-200A/HY-200B/HY-420A/HY-200D/HY-200C)Shenzhen Kaiyan Medical Equipment Co., Ltd.20260—
+5K260153Q-Switched Nd: YAG Laser System (Glamor Q)Nanjing Bestview Laser S&T Co., Ltd.20260—
+5K260129Lumaflex Panel (ZLD-05, ZLD-05A, ZLD-05APro )Shenzhen Kaiyan Medical Equipment Co., Ltd.20261—
+5K260511Ulike Reglow Light Therapy Device (UM10)Shenzhen Ulike Smart Electronics Co., Ltd.20260—
+5K243854Contour Light (CL-100)Contour Research, LLC20261—
+5K253054LED Light Therapy Mask (M19, M19-1, M19-2, M19-3, M19-5, M19-6)Shenzhen Xinlong Precision Plastic Mold Products Co., Ltd.20250—
+5K252786Led Light Phototherapy Bed (Pro 450/ GY-680A)Shenzhen Suyzeko Limited.20250—
+5K252658Medical Diode Laser Systems (TR-B)Baoding Te'Anzhou Electronic Technology Co., Ltd.20251—
+5K252272ORA Method LED Gua Sha (GS-04)Shenzhen Kaiyan Medical Equipment Co., Ltd.20250—
+5K251699The Botticelli (Model: Athena)Bellamia Technologies, Inc.20250—
+5K251727GLAM LED Facial Mask (TB-2386F)Touchbeauty Beauty & Health (Shenzhen) Co., Ltd.20250—
+5K250261Heager Medical Laser Family (Sabrina/Adolf)Heager GmbH20250—
+5K251588LED Light Therapy Mask (FCM902, FCM905, FCM906, FCM908, 11-001-RBMASK, FCM910)Shenzhen Fittop Health Technology Co., Ltd.20252—
+5K251076Diode Laser Hair Removal Machine (models: T60A, T60B, T60C, T60D, T60E)Shenzhen Lifotronic Technology Co., Ltd.20250—
+5K252215InbellaMAX SystemInbella Medical, Ltd.20250—
+5K250761KALA Therapy Wand (Model: KALA-03)Shenzhen Kaiyan Medical Equipment Co., Ltd.20251—
+5K250165PastelleWontech Co., Ltd.20250—
+5K251031Fiber Laser Treatment Systems (HS-232,HS-233)Shanghai Apolo Medical Technology Co., Ltd.20250—
+5K250936Q-Switched Nd:YAG Laser (SHE-LSP101-1)Beijing Sano Laser S&T Development Co.,Ltd20250—
+5K242996EndyMed PRO MAXEndymed Medical, Ltd.20251—
+5K250722Nd: YAG Laser Therapy System (QN-1)Hebei JT Medical Co., Ltd.20250—
+5K242151Radiant Renewal Skincare Wand (HD-44,HD-44A ,HD-44B,HD-44C, HD-69, HD-69A, HD-69B)Shenzhen Nuon Medical Equipment Co., Ltd.20251—
+5K250189AdvaTxAdvalight Aps20250—
+5K250125LMNT O2Xplr, Ltd.20250—
+5K241791Medical Diode Laser Systems (GBOX-6H, GBOX-10D , GBOX-12D, GBOX-15D, VELAS Pro-30B15D…Gigaalaser Company, Ltd.20251—
+5K244022308nm UV Phototherapy System (UV-K); 308nm UV Phototherapy System (UV-X); 308nm UV…Boston Aesthetics, Inc.20250—
+5K234004Medical diode laser systems (CHARISMA, REGAL)Reveal Lasers, Ltd.20251—
+5K243488Vmat ProTermosalud20250—
+5K243037Diode Laser System model Dawn-SShanghai Wonderful Opto-Electrics Tech.Co.,Ltd20240—
+5K243430Micro-current Facial Beauty Device (AM-810B, AM-810W, AM-812B, AM-812W)Shenzhen Aozemei Technology Co., Ltd.20243—
+5K241771Liftendo; Liftendo 2.0Medical San Indústria DE Equipamentos Médicos Ltda.20240—
+5K241102Luna 4 plusForeo, Inc.20245—
+5K240222Dermalux Tri-Wave MD MKII (1000021); Dermalux Compact MD (1000024)Aesthetic Technology, Ltd.20240—
+5K233803UltraClear Laser System (N/A)Acclaro Corporation20241—
+5K240179Medical Diode Laser (Model: L2)Wuhan Pioon Technology Co., Ltd.20242—
+5K240132EmoLED (v. 2-USA)Emoled, Srl20240—
+5K233224Epilaser ProEpilady 2000, LLC20240—
+5K233550MOSAIC 3D (Surgical Laser)Lutronic Aesthetic20240—
+5K232977Biophotas Celluma CONTOURBiophotas, Inc.20235—
+5K232656BLU TOTALE (Model: ENEOB852)Premier North America, Inc.20232—
+5K230490PMD Clean Acne, Model: 4004-CABLUE-NA, 4004-GREY-NA, 4004-YELLOW-NA, 4004-PSTO-NA…Dongguan Hunter Electronic Technology Co., Ltd.20230—
+5K230013Silk'n Titan AllwaysSilk'N Beauty, Ltd.20230—
+5K231394Intense Pulsed Light SystemSmedtrum Medical Technology Co., Ltd.20232—
+5K231555LUMA LED patches (LUMA Blemish (TN2197) and LUMA Revive (TN2189))iSMART Developments, Ltd.20231—
+5K230077LaserMENeauvia North America20232—
+5K230720LUSTRE 3XPRESS Light Beauty Therapy patches, model: PR6001, PR5001Light Tree Ventures Europe B.V.202318—
+5K223147myLEDmaskMyblend20234—
+5K221865BTL-094BTL Industries, Inc.20230—
+5K230274Medical Diode Laser (M2)Wuhan Pioon Technology Co., Ltd.20232—
+5K222685NIRA Model 2Dermal Photonics Corp20230—
+5K210166Omnispec ED1000Medispec, Ltd.20230—
+5K223647CLEAR+BRILLIANT TOUCH® Laser SystemSolta Medical, Inc.20220—
+5K221268SR-1 Skin Treatment SystemAVAVA, Inc.20223—
+5K222800Diode Laser Hair Removal Systems for Medical Use (Models: Milestone Smart-M, Milestone…Sanhe Laserconn Tech Co., Ltd.20220—
+5K221712Fotona XPulse Laser System Family (XPulse 1064 nm, XPulse 810 nm, XPulse 980 nm)Fotona D.O.O.20221—
+5K221189Oliz LTB-1000ALtbio Co., Ltd.20220—
+5K221430reVive Light Therapy LED Cleansing SystemLed Technologies, Inc.20220—
+5K221083Smartlux MiniMedmix Co., Ltd.20222—
+5K220538DolorClast RadialE.M.S Electro Medical Systems S.A20221—
+5K220729The Luminance RED Acne DeviceLuminance Medical Ventures, Inc.20221—
+5K213332Multifrax Laser SystemParadigm Medical Corporation20220—
+5K210545Infrared Red blue LED light heat beauty machine, Infrared Red blue LED light heat beauty…Marci Beauty, Inc.20222—
+5K210183Waterlase iPLusBiolase, Inc.20220—
+5K213534PHantom TrilogyResurgeonz, LLC20220—
+5K213841ENEO TOTALE (Model: ENEOT947)Premier North America, Inc.20222—
+5K210968reVive Light Therapy EssentialsLed Technologies, Inc.20213—
+5K212492Frax 1940 for Nordlys and Frax ProCandela Corporation20210—
+5K210847UltraClear Fractional Laser SystemFa International, LP20210—
+5K202288FinebeamSNJ Co., Ltd.20212—
+5K212607DarwinLuvo Medical Technologies, Inc.20210—
+5K201520The Alma Opus System, Colibri Applicator and TipsAlma Lasers, Inc.20211—
+5K212270DEKA LipoAIEl.En Electronic Engineering Spa20210—
+5K200983Infrared light therapy led facial light therapy mask-Derma plus, Photons Facial Skin…Ningbo Hesi Electric Co., Ltd.202146—
+5K202991Fotona XPulse Pro Laser PlatformFotona D.O.O.20213—
+5K210451OrthoGold 100Tissue Regeneration Technologies, LLC20212—
+5K202055Looper (Model: ZX-579S)Heat IN A Click, LLC20213—
+5K203299CellFX SystemPulse Biosciences, Inc.20214—
+5K202028dermalux Flex MDAesthetic Technology, Ltd.20205—
+5K200971308nm Excimer SystemXuzhou Kernel Medical Equipment Co., Ltd.20201—
+5K202827308nm Excimer UV-light Skin Therapy SystemShenzhen Gsd Tech Co., Ltd.20200—
+5K201064V30 System, V20 System, V10 System, V-FR HandpieceViora, Ltd.20200—
+5K192642308nm Excimer SystemChongqing Peninsula Medical Technology Co., Ltd.20202—
+5K192295PDT-FaceBeijing Adss Development Co., Ltd.202046—
+5K192951Ellipse Frax 1940 for Ellipse Nordlys and Ellipse YdunEllipse A/S20201—
+5K193367elysion-proHigh Technology Products S.L.U20203—
+5K193446Bare: 808Luvo Medical Technologies, Inc.20202—
+5K191086ExciplexClarteis20194—
+5K192521Intense Pulsed Light Treatment SystemShangdong Huamei Technology Co., Ltd.20193—
+5K192269TwinScan 808/755 Laser SystemGme German Medical Engineering GmbH20190—
+5K192331LaseMD LEO Laser SystemLutronic Global20190—