510(k) Report

Devices descending from K991935

1,492 later devices reach Epilight Hair Removal System, Photoderm HR System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K261214Pico Shining (Pico-K; Picofy)Speclipse, Inc.20260—
+6K253251Leaseir MHR Xcell (console) (MHR-100b); Handpiece: Dual (810-b and Blend-b); Handpiece…Leaseir Technologies, Slu20260—
+6K260688Sculpt LED Belt (HY-150A/HY-150B/HY-200A/HY-200B/HY-420A/HY-200D/HY-200C)Shenzhen Kaiyan Medical Equipment Co., Ltd.20260—
+6K260518IPL Hair Removal (SL-B301, SL-B300, SL-B330, SL-B330-1, SL-B287-1, SL-B371, SL-B371-2…Shenzhen Semlamp Intelligent Technology Co., Ltd.20260—
+6K260129Lumaflex Panel (ZLD-05, ZLD-05A, ZLD-05APro )Shenzhen Kaiyan Medical Equipment Co., Ltd.20261—
+6K260632Laser Thermal Therapy KitElesta S.P.A20260—
+6K260511Ulike Reglow Light Therapy Device (UM10)Shenzhen Ulike Smart Electronics Co., Ltd.20260—
+6K243854Contour Light (CL-100)Contour Research, LLC20261—
+6K251988Boston iFace (Boston iFace)Boston Aesthetics, Inc.20260—
+6K253054LED Light Therapy Mask (M19, M19-1, M19-2, M19-3, M19-5, M19-6)Shenzhen Xinlong Precision Plastic Mold Products Co., Ltd.20250—
+6K252786Led Light Phototherapy Bed (Pro 450/ GY-680A)Shenzhen Suyzeko Limited.20250—
+6K252658Medical Diode Laser Systems (TR-B)Baoding Te'Anzhou Electronic Technology Co., Ltd.20251—
+6K253304IPL Hair Removal Device (KA-10, KA-11, KA-11C, KA-11D, KA-18, KA-20, KA-21, KA-21C)Dongguan Lide Electric Appliance Co., Ltd.20250—
+6K250852CoolfaseAsterasys Co., Ltd.20250—
+6K252209IPL Home Use Hair Removal Device (JD-TM016, JD-TM023, JD-TM027, JD-TM028, JD-TM032)Foshan Jindi Electric Appliance Co., Ltd.20251—
+6K252272ORA Method LED Gua Sha (GS-04)Shenzhen Kaiyan Medical Equipment Co., Ltd.20250—
+6K251464TRI-BEAM PRO, TRI-BEAM (Nd:YAG Laser unit)Jeisys Medical Incorporated20250—
+6K251398IPL Hair Removal Device (IPL-001, IPL-002)Shenzhen Enmind Technology Co., Ltd.20250—
+6K252063Medical Diode Laser Systems (BERYLAS-12N); Medical Diode Laser Systems (BERYLAS-15N)…Wuhan Dimed Laser Technology Co., Ltd.20250—
+6K242859VEGAIbramed Equipamentos Médicos20250—
+6K251727GLAM LED Facial Mask (TB-2386F)Touchbeauty Beauty & Health (Shenzhen) Co., Ltd.20250—
+6K250261Heager Medical Laser Family (Sabrina/Adolf)Heager GmbH20250—
+6K251588LED Light Therapy Mask (FCM902, FCM905, FCM906, FCM908, 11-001-RBMASK, FCM910)Shenzhen Fittop Health Technology Co., Ltd.20252—
+6K251176IPL Hair Removal Device (Model (s): T14B, T16B, T19B, T15B, T17C, T18B, T21A, T21B…Shenzhen Mlay Intelligent Technology Co.,, Ltd.20251—
+6K251327XERFLutronic Corporation202501
+6K251076Diode Laser Hair Removal Machine (models: T60A, T60B, T60C, T60D, T60E)Shenzhen Lifotronic Technology Co., Ltd.20250—
+6K252215InbellaMAX SystemInbella Medical, Ltd.20250—
+6K251984Ice Cooling IPL Hair Removal Device (UI06S PR, UI06S PN, UI06S WH, UI06S PRU, UI06S PNU…Shenzhen Ulike Smart Electronics Co., Ltd.20250—
+6K250761KALA Therapy Wand (Model: KALA-03)Shenzhen Kaiyan Medical Equipment Co., Ltd.20251—
+6K250942Ice Cooling IPL Hair Removal Device (UI20S DB, UI20S RE, UI20S PW, UI20S GP, UI20S GR…Shenzhen Ulike Smart Electronics Co., Ltd.20253—
+6K243123IPL Treatment Device (MDSQMC-01)Medusa (Guangxi)Medical Devices Co., Ltd.20250—
+6K251031Fiber Laser Treatment Systems (HS-232,HS-233)Shanghai Apolo Medical Technology Co., Ltd.20250—
+6K251000Hand-held Hair Removal Device (FZ-200A, FZ-201, FZ-202, CT05, CT06, CT07, CT08, CT09)Shenzhen Chuangtong Yigou Technology Co., Ltd.20251—
+6K251329Diode laser device (RF3120-BI)Risu Medical Technology Co., Ltd.20252—
+6K243036IPL Hair Removal Device (BHRL-01, BHRL-02, BHRL-03, BHRL-04, BHRL-05, BHRL-06, BHRL-06B…Bestway Plastic and Metal Products, Ltd.20251—
+6K251230The Alma Hybrid Laser SystemAlma Lasers, Inc.20250—
+6K240857Youmagic FLM System (YM5-U1)We Medical Technology (Wuxi) Co., Ltd.20250—
+6K250206Diode laser system (Night Universe; Predator)Ivylaser (Beijing) Technology Co.,Ltd20250—
+6K250809Stellar M22Lumenis Be, Ltd.20250—
+6K242151Radiant Renewal Skincare Wand (HD-44,HD-44A ,HD-44B,HD-44C, HD-69, HD-69A, HD-69B)Shenzhen Nuon Medical Equipment Co., Ltd.20251—
+6K250656Medical Diode Laser (Models: MZ-GK, MZ-K20, MZ-N75)Wuhan Pioon Technology Co., Ltd.20250—
+6K250194Ice Cooling IPL Hair Removal Device (UI06S PR, UI06S PN, UI06S WH)Shenzhen Ulike Smart Electronics Co., Ltd.20252—
+6K250125LMNT O2Xplr, Ltd.20250—
+6K242241SunnyShenB Co., Ltd.20250—
+6K244022308nm UV Phototherapy System (UV-K); 308nm UV Phototherapy System (UV-X); 308nm UV…Boston Aesthetics, Inc.20250—
+6K240311JETT Medical IICompex, Spol, S.R.O.20250—
+6K233118DUET-V (Model: ESK-3261DV)Eunsung Global Corp20250—
+6K243037Diode Laser System model Dawn-SShanghai Wonderful Opto-Electrics Tech.Co.,Ltd20240—
+6K243085IPL Hair Removal Device (DE03A-W, DE03A-P, DE03A-V, DE03A-G, DE03B-W, DE03B-P, DE03B-V…Zhuzhou Goldenhot Medical Technology Co., Ltd.20240—
+6K242688Finiff SystemSkingrab Co., Ltd.20240—
+6K243430Micro-current Facial Beauty Device (AM-810B, AM-810W, AM-812B, AM-812W)Shenzhen Aozemei Technology Co., Ltd.20243—
+6K241998Ice Cooling IPL Hair Removal Device (UI20 DB, UI20 RE, UI20 GP, UI20 PW, UI20S DB, UI20S…Shenzhen Ulike Smart Electronics Co., Ltd.20246—
+6K242440Intense Pulsed Light Treatment System (LK-PT)Nanjing Bestview Laser S&T Co., Ltd.20240—
+6K242039Ice Cooling IPL Hair Removal Device (UIM20 GR, UIM20 BK, UIM20 SL, UIM20 CB, UIM20 WR)Shenzhen Ulike Smart Electronics Co., Ltd.202413—
+6K243030Diamond Air+ (UI04A, UI04B, UI04C, UI04M, UI04G, UI04W)Ulike Co., Ltd.20240—
+6K242197IPL Hair Removal Device (DH4, DH5, DH5 Plus, DH5 Max)Shenzhen Huaruibo Electric Appliances Co., Ltd.20240—
+6K241092Youlaser PRIME; Youlaser PRIME CO2; Youlaser PRIME MTQuanta System Spa20240—
+6K241834IPL Hair Removal Device (BE932C, BE932D, BE932E)Shenzhen Yang WO Electronic Co., Ltd.20242—
+6K241771Liftendo; Liftendo 2.0Medical San Indústria DE Equipamentos Médicos Ltda.20240—
+6K241205Ice Cooling IPL Hair Removal Device (Y6S GR, Y6S GA,Y6S GT, Y6S JU, Y6S JM, Y6S MU, Y6S…Shenzhen Ulike Smart Electronics Co., Ltd.20242—
+6K242202LightWalker Laser System FamilyFotona D.O.O.20241—
+6K241102Luna 4 plusForeo, Inc.20245—
+6K241656Eneka SelectifTermosalud20241—
+6K240016IPL Hair Removal Device (YT01,YT02,YT03,YT04)Shenzhen Jianrong Biomedical Electronics Co., Ltd.20249—
+6K241343IPL Hair Removal Device (LS-T121, LS-T121A, LS-T121B, LS-T121C, LS-T130, LS-T130A…Shenzhen Lescolton Electrical Appliance Co., Ltd.20241—
+6K241600DermablateAsclepion Laser Technologies GmbH20240—
+6K240611IVYLASER Diode laser hair removal system (IVY-HR-Alloy)Ivylaser (Beijing) Technology Co.,Ltd20240—
+6K240583IPL Home Use Hair Removal Device (D-1199, D-T099, D-T018, D-T019, D-T003B, D-T003W…Shenzhen Beauty Every Moment Intelligent Electric Co., Ltd.20240—
+6K240747Medical Diode Laser (M2-GK)Wuhan Pioon Technology Co., Ltd.20244—
+6K240017InMode System with the Morpheus8 90 ApplicatorInMode, Ltd.20240—
+6K240644Medical Diode Laser (S1Pro)Wuhan Pioon Technology Co., Ltd.20242—
+6K240222Dermalux Tri-Wave MD MKII (1000021); Dermalux Compact MD (1000024)Aesthetic Technology, Ltd.20240—
+6K241106Ice Cooling IPL Home Use Hair Removal Device (Model (s): T10B, T10C, T15A, T17A, T18A…Shenzhen Mlay Intelligent Technology Co.,, Ltd.20242—
+6K240482Intense Pulsed Light System (ST-690)Smedtrum Medical Technology Co., Ltd.20241—
+6K240248Volnewmer™Classys, Inc.20241—
+6K240093IPL Home Use Hair Removal Device (SJ15)Shenzhen Shuge Medical Beauty Devices Co., Ltd.20240—
+6K240816MeDioStarAsclepion Laser Technologies GmbH20240—
+6K233849BTL-499BTL Industries, Inc.20240—
+6K233604BTL-785SBTL Industries, Inc.20243—
+6K240132EmoLED (v. 2-USA)Emoled, Srl20240—
+6K240396Elite iQ PRO (M122K1)Cynosure, LLC20240—
+6K232885Dawn Diode Laser SystemShanghai Wonderful Opto-Electrics Tech.Co.,Ltd20240—
+6K233760Mjolnir Pro. (Multi–electrode plasma)Shenzhen Leaflife Technology Co., Ltd.20240—
+6K233143PiXel8-RevealRohrer Aesthetics20240—
+6K233224Epilaser ProEpilady 2000, LLC20240—
+6K233550MOSAIC 3D (Surgical Laser)Lutronic Aesthetic20240—
+6K23299210THERMATentech, Inc.20230—
+6K232977Biophotas Celluma CONTOURBiophotas, Inc.20235—
+6K232656BLU TOTALE (Model: ENEOB852)Premier North America, Inc.20232—
+6K230490PMD Clean Acne, Model: 4004-CABLUE-NA, 4004-GREY-NA, 4004-YELLOW-NA, 4004-PSTO-NA…Dongguan Hunter Electronic Technology Co., Ltd.20230—
+6K231092T-Shape 2B&M S.R.L. Marketing Nel Benessere20230—
+6K232183IPL Hair Removal Device, Model (s): T1, T2, T3, T7, T10Shenzhen Koli Technology Co.,Ltd20230—
+6K232124IPL Hair Removal, Model: W-1095, W-1098Shenzhen Wochuan Electronic Co., Ltd.20230—
+6K231146AliTightAlic Iotech, LLC20230—
+6K231800IPL Hair Removal Device, Model (s): JP1, JR3, JR8, JR9Shenzhen Qianyu Technology Co., Ltd.20231—
+6K230013Silk'n Titan AllwaysSilk'N Beauty, Ltd.20230—
+6K230663DensityJeisys Medical, Inc.20232—
+6K222862SILKPRO Titanium Diode Laser System SILKPRO-S20S-TWCLotuxs Medtech (Suzhou) Co., Ltd.20231—
+6K231555LUMA LED patches (LUMA Blemish (TN2197) and LUMA Revive (TN2189))iSMART Developments, Ltd.20231—
+6K230720LUSTRE 3XPRESS Light Beauty Therapy patches, model: PR6001, PR5001Light Tree Ventures Europe B.V.202318—