510(k) Report

Devices descending from K955612

1,548 later devices reach RD-1200H Normal Mode Ruby Laser System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+10K253878LUSTRE GoGlow Advanced LED Patches (PR8001, PR9001)Shenzhen Kaiyan Medical Equipment Co., Ltd.20260—
+10K253874LED Therapy Light (COB1400, HP1800PRO)Shenzhen Hanhua Opto Co., Ltd.20260—
+10K253833Facial & Body Beauty Device (model: INIA-BD001, INIA-BD002, INIA-BD003, INIA-BD004…Shenzhen Jianchao Intelligent Technology Co., Ltd.20260—
+10K251981Boston PICO (Boston PICO)Boston Aesthetics, Inc.20260—
+10K254290ZenTite (Unicorn+); ZenTite (Unicorn+I); ZenTite (Unicorn+II); ZenTite (Unicorn+III)Shenzhen Peninsula Medical Group20260—
+10K252369Boston Pico755Boston Aesthetics, Inc.20260—
+10K253279Feather/numiere 05 06 07 (05)Heat IN A Click, LLC20250—
+10K252187Aura Glide (FC40)Aura Medical, LLC20250—
+10K252146Multi-functional Facial Beauty Device ( SKB-1703,SKB-1803,SKB-1909, SKB-2003…Shenzhen Siken 3D Technology Development Co., Ltd.20251—
+10K251730LIA Console (542-7)Leadoptik, Inc.20250—
+10K253123CuRAS hybridClassys, Inc.20250—
+10K252515Q-Switched Nd:Yag laser (K690)Hebei Keylaser Sci-Tech Co.,Ltd20250—
+10K252319Q-Switched Nd: YAG Laser machine (LFS-C13U)Sanhe Lefis Electronics Co., Ltd.20250—
+10K252155AVAVA™ Skin Treatment SystemAVAVA, Inc.20250—
+10K250731MateLaser Medical Diode Laser Systems (ML-DLS-30)Matelaser, Inc.20250—
+10K251919Thulium Laser System (Deluxlase)Nanjing Bestview Laser S&T Co., Ltd.20250—
+10K251914IPL Hair Removal Device (MLY-M011); IPL Hair Removal Device (MLY-M012); IPL Hair Removal…Miley Technology (Hebei) Co., Ltd.20250—
+10K251843Erchonia EVRLErchonia Corporation20250—
+10K251667LED Light Therapy Mask (M01, M02, M06, M07, M08, M09)Shenzhen Liyoutong Technology Co., Ltd.20250—
+10K251339Medical Diode Laser Hair Removal Device (PZ-606¿, PZ-BDT68-01, PZ-BDT68-02, PZ-BDT68-03…Zhengzhou PZ Laser Slim Technology Co., Ltd.20250—
+10K251042Light Therapy System (M500, L6)Guangzhou Ahead Intelligent Technology Co., Ltd.20251—
+10K250532Solawave 2-in-1 Skincare Mini (Model: 61043)Shenzhen Kaiyan Medical Equipment Co., Ltd.20251—
+10K243176BLESSING SystemCellah Medical Co., Ltd.20251—
+10K243764Medical Diode Laser (UTU3-F7B,UTU3-F7W,UTU3-G7B,UTU3-G7W,UTU-G20B,UTU-G20W)Wuhan Pioon Technology Co., Ltd.20250—
+10K250018Medical Diode Laser Systems (THEIA808)Gigaalaser Company, Ltd.20250—
+10K243957PicoalexWontech Co., Ltd.20250—
+10K241947EnergyLounger (TY-01)Shenzhen Kaiyan Medical Equipment Co., Ltd.20251—
+10K250200InbellaBody SystemInbella Medical, Inc.20250—
+10K243555LED light therapy mask (E43, E32, E49B, E49C, E100B, E100C, E103B, E104B, E106A, E108A)Shenzhen Eyco Technology Co., Ltd.20250—
+10K243393JMOON NouvelleSkin Facial Toning Device (M30U PR, M30U MW, M30U SG, M30U SK, M30U MP)Shenzhen Ulike Smart Electronics Co., Ltd.20251—
+10K243423LED Light Therapy Mask (Model (s): RB-008, RB-030, RB-081, RB-008G, RB-008GB, RB-008J…Shenzhen Rainbow Technology Co., Ltd.20253—
+10K243929Oligio XWontech Co., Ltd.20250—
+10K242789Bestqool LED Therapy Device (LMK-001,LMK-004,LMK-005,LMK-006)Dongguan Laiguang Electronic Technology Co., Ltd.20253—
+10K242534HandPICO Fractional Laser Handpiece TipVydence Medical20241—
+10K231216PotenzaJeisys Medical, Inc.20244—
+10K231287PotenzaJeisys Medical, Inc.20241—
+10K241718Micro-current Facial Beauty Device (AM-810B, AM-810W, AM-812B, AM-812W)Shenzhen Aozemei Technology Co., Ltd.202412—
+10K240991eMVFit (MVF-10M)Weero Co., Ltd.20240—
+10K241881IPL Hair Removal Device (JM-843, JM-865, JM-638)Shenzhen Junmei Technology Co., Ltd.20241—
+10K241203PMD Clean Redvolution (4005-moab-NA, 4005-moab-INT, 4005-pepper-NA, 4005-pepper-INT…Dongguan Hunter Electronic Technology Co., Ltd.20240—
+10K241406LavieenWontech Co., Ltd.20242—
+10K233123SilkroHironic Co., Ltd.20241—
+10K241459MOTUS PRO FamilyEl.En S.P.A.20240—
+10K233120CWM-930S, Fixer DV9Chungwoo Co., Ltd.20240—
+10K233099GladiatorRohrer Aesthetics, LLC20240—
+10K240520Diode Laser Hair Removal System (SH-VD910)Beijing Sea Heart International Science and Technologyco.Ltd20240—
+10K240386Picosecond Nd:YAG Laser Systems (BL-C10)Shanghai Bele Medical Technology Co.,Ltd20240—
+10K240999Legend X Applicator VOPollogen, Ltd.20241—
+10K233962ReBorn (1050nm)Lightfective, Ltd.20240—
+10K240360Wrinkle Treatment Device (JM2)Shenzhen Qianyu Technology Co., Ltd.20242—
+10K234085LUNE™ PureHygieneEnamel Pure20241—
+10K230047Medical Diode Laser SystemsGigaalaser Company, Ltd.20242—
+10K230837PlazMagikAgnes Medical Co., Ltd.20240—
+10K232863Radiant Renewal Skincare Wand (HD-15, HD-15A)Shenzhen Kaiyan Medical Equipment Co., Ltd.20230—
+10K232708Intense pulsed light therapy deviceHebei Zhemai Technology Co., Ltd.20230—
+10K233147PiXel8-RFRohrer Aesthetics20230—
+10K232223PlaDuo SystemShenB Co., Ltd.20230—
+10K232499IPL Hair Removal Device (LS-T106, LS-T107, LS-T108)Shenzhen Lescolton Electrical Appliance Co., Ltd.20234—
+10K223919B.Light Clear Evo and B.Light Restore EvoBemer Int AG20232—
+10K231790The InMode System with the Morpheus8 ApplicatorsInMode, Ltd.202310—
+10K230293TheraFace MaskTherabody, Inc.202316—
+10K230373HELIOS 785 PicoLaseroptek Co., Ltd.20232—
+10K223893Infrared Heat (Model: E0221)Light Tree Ventures Europe B.V.20235—
+10K220322Pollogen STOP U Model UXV DevicePollogen, Ltd.20233—
+10K230042Q-Rejuvalight Pro Facewear (Model: P19-0023)Light Tree Ventures Europe B.V.20239—
+10K230097IPL Hair Removal Device, Model (s): BSXT101, BSXT102, BSXT103, BSXT105, BSXT106, BSXT108Shenzhen Bsx Technology Electronics Co., Ltd.20238—
+10K223778Diode Laser Hair Removal System (RD-SLD600)Shanghai Omni Laser Skinology Co., Ltd.20230—
+10K222260Capenergy C Equipment RF System - C25, C50, C100, C200, C300, C400, C500Capenergy Medical S.L.20233—
+10K222709Retraction, CWM-910T, APOLEX TiteChungwoo Co., Ltd.20230—
+10K223544LED light therapy mask (FM-01, FM-02, FM-03)Guangdong Newdermo Biotech Co., Ltd.202339—
+10K221873NeoGen PSR SystemEnergist Limited20230—
+10K223482reVive Light Therapy® Wrinkle and Acne LED DeviceLed Technologies, Inc.20222—
+10K222916US 450 Diode Laser EquipmentBeijing Globalipl Development Co., Ltd.20220—
+10K221444LED Eye Perfector, model: EY-36A, EY-36BLight Tree Ventures Europe B.V.20223—
+10K222710IPL Cooling Hair Removal DeviceShenzhen Siken 3D Technology Development Co., Ltd.20220—
+10K222377Led Mask Platinum MdCellreturn Co., Ltd.20224—
+10K220853PicoWay Laser SystemCandela Corporation20221—
+10K222432IPL Hair Removal Device, Model (s): KCA423, KCA437, KCA439Hunan Guangye Biotechnology Co., Ltd.20220—
+10K222316IPL Hair Removal DeviceShenzhen Goodwind Technology Development Co., Ltd.20221—
+10K214015Palm NRG cellulite body device (model: Palm NRG body device)Heat IN A Click, LLC20220—
+10K222555reepot Nd; YAG laser systemIlooda Co,., Ltd.20220—
+10K222265DiosculptShanghai Wonderful Opto-Electrics Tech.Co.,Ltd20220—
+10K221466IPL Hair Removal Device, model: AI01, AI06, AI08, AI16, AI17Shenzhen Century Dongyuan Technology CO, Ltd.20220—
+10K220064Synergy Marble (Model: Opasm)Yrs Group, Inc.20220—
+10K221407truSculpt iDCutera, Inc.20222—
+10K212472AgeJetTriworks Group Srl20220—
+10K220248Home use hair removal deviceShenzhen Mareal Tech Co., Ltd.20228—
+10K211000AcutronIlooda Co,., Ltd.20220—
+10K211652Renuvion Dermal Handpiece, Renuvion Dermal SystemApyx Medical Corporation (Formerly Bovie Medical Corporation20220—
+10K220669IPL HAIR REMOVAL HANDSET, Model: IPL-666Shenzhen Junbobeauty Technology Co., Ltd.20222—
+10K220222IPL Hair Removal Device, model (s): S1-A, S2-A, S1, S2, S3, S4Shenzhen Yuwei Electronic Technology Co., Ltd.202213—
+10K211681EONDominion Aesthetic Technologies, Inc.20221—
+10K214101Project E Beauty LED Light Therapy Mask (Model: PE730)Duplex International Trading Limited20220—
+10K212478Dermatological diode laser systemBeijing Stelle Laser Technology Co., Ltd.20220—
+10K212318IPL Hair RemovalDongguan Define Beauty Electronic Technology Co., Ltd.202226—
+10K213308Venus BlissMAXVenus Concept USA, Inc.20222—
+10K212127PicocaremajestyWontech Co., Ltd.20226—
+10K213225Diode Laser System GP900A8, Diode Laser System GP900Q8Shenzhen Gsd Tech Co., Ltd.20210—
+10K212155TheraFace LEDTheragun, Inc.202142—
+10K213020IPL hair removal machineShenzhen Borria Technology Co., Ltd.20210—