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
+9K250041Medical Picosecond ND: YAG Laser System (PZ-6)Zhengzhou PZ Laser Slim Technology Co., Ltd.20250—
+9K250402AVAVA™ Skin Treatment SystemAVAVA, Inc.20251—
+9K250194Ice Cooling IPL Hair Removal Device (UI06S PR, UI06S PN, UI06S WH)Shenzhen Ulike Smart Electronics Co., Ltd.20252—
+9K250125LMNT O2Xplr, Ltd.20250—
+9K241832Unicorn+ RF System (Unicorn+); Unicorn+ RF System (Unicorn+ I); Unicorn+ RF System…Boston Aesthetics, Inc.20251—
+9K243139Reverso Pro SystemIndiba S. A. U.20250—
+9K243085IPL Hair Removal Device (DE03A-W, DE03A-P, DE03A-V, DE03A-G, DE03B-W, DE03B-P, DE03B-V…Zhuzhou Goldenhot Medical Technology Co., Ltd.20240—
+9K243430Micro-current Facial Beauty Device (AM-810B, AM-810W, AM-812B, AM-812W)Shenzhen Aozemei Technology Co., Ltd.20243—
+9K242532BTL-785BNF-EBTL Industries, Inc.20241—
+9K240897CellinewVIOL Co., Ltd.20240—
+9K242440Intense Pulsed Light Treatment System (LK-PT)Nanjing Bestview Laser S&T Co., Ltd.20240—
+9K242039Ice Cooling IPL Hair Removal Device (UIM20 GR, UIM20 BK, UIM20 SL, UIM20 CB, UIM20 WR)Shenzhen Ulike Smart Electronics Co., Ltd.202413—
+9K243030Diamond Air+ (UI04A, UI04B, UI04C, UI04M, UI04G, UI04W)Ulike Co., Ltd.20240—
+9K242183Fractional CO2 Laser Therapy System (EXFU CO2)Weifang Mingliang Electronics Co., Ltd.20240—
+9K242197IPL Hair Removal Device (DH4, DH5, DH5 Plus, DH5 Max)Shenzhen Huaruibo Electric Appliances Co., Ltd.20240—
+9K241951Lasya-TrinityBLUECORE COMPANY Co., Ltd.20240—
+9K242206ActivoDaeju Meditech Engineering Co., Ltd.20240—
+9K241834IPL Hair Removal Device (BE932C, BE932D, BE932E)Shenzhen Yang WO Electronic Co., Ltd.20242—
+9K241205Ice 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—
+9K241102Luna 4 plusForeo, Inc.20245—
+9K240016IPL Hair Removal Device (YT01,YT02,YT03,YT04)Shenzhen Jianrong Biomedical Electronics Co., Ltd.20249—
+9K241343IPL Hair Removal Device (LS-T121, LS-T121A, LS-T121B, LS-T121C, LS-T130, LS-T130A…Shenzhen Lescolton Electrical Appliance Co., Ltd.20241—
+9K240583IPL 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—
+9K241407Splendor X (Alex, Alex2, Nd:YAG, Alex+Nd:YAG)Bios S.R.L.20240—
+9K240222Dermalux Tri-Wave MD MKII (1000021); Dermalux Compact MD (1000024)Aesthetic Technology, Ltd.20240—
+9K233344Regenalase Laser SystemIpg Medical20240—
+9K241106Ice Cooling IPL Home Use Hair Removal Device (Model (s): T10B, T10C, T15A, T17A, T18A…Shenzhen Mlay Intelligent Technology Co.,, Ltd.20242—
+9K240482Intense Pulsed Light System (ST-690)Smedtrum Medical Technology Co., Ltd.20241—
+9K240118Picosecond Nd:YAG Laser SystemSmedtrum Medical Technology Co., Ltd.20240—
+9K240093IPL Home Use Hair Removal Device (SJ15)Shenzhen Shuge Medical Beauty Devices Co., Ltd.20240—
+9K222958mJOULE RF System and AccessoriesSciton, Inc20240—
+9K233757TitanPico Laser Workstation (PICO-450)Rhein Laser Technologies Co., Ltd.20240—
+9K240132EmoLED (v. 2-USA)Emoled, Srl20240—
+9K240396Elite iQ PRO (M122K1)Cynosure, LLC20240—
+9K240313Oligio XWontech Co., Ltd.20241—
+9K231896Diode Laser Therapy SystemBeijing Adss Development Co., Ltd.20240—
+9K233143PiXel8-RevealRohrer Aesthetics20240—
+9K232222Primo Dental Laser (Primo, Primo Komfort, Primo Lite, Primo Blue, and Primo Triplo)Medency S.R.L.20230—
+9K232977Biophotas Celluma CONTOURBiophotas, Inc.20235—
+9K232656BLU TOTALE (Model: ENEOB852)Premier North America, Inc.20232—
+9K230490PMD Clean Acne, Model: 4004-CABLUE-NA, 4004-GREY-NA, 4004-YELLOW-NA, 4004-PSTO-NA…Dongguan Hunter Electronic Technology Co., Ltd.20230—
+9K231495The Evolve System with the Transform ApplicatorInMode, Ltd.20231—
+9K231092T-Shape 2B&M S.R.L. Marketing Nel Benessere20230—
+9K232183IPL Hair Removal Device, Model (s): T1, T2, T3, T7, T10Shenzhen Koli Technology Co.,Ltd20230—
+9K232124IPL Hair Removal, Model: W-1095, W-1098Shenzhen Wochuan Electronic Co., Ltd.20230—
+9K231800IPL Hair Removal Device, Model (s): JP1, JR3, JR8, JR9Shenzhen Qianyu Technology Co., Ltd.20231—
+9K230013Silk'n Titan AllwaysSilk'N Beauty, Ltd.20230—
+9K223727LavieenWontech Co., Ltd.20234—
+9K231555LUMA LED patches (LUMA Blemish (TN2197) and LUMA Revive (TN2189))iSMART Developments, Ltd.20231—
+9K230720LUSTRE 3XPRESS Light Beauty Therapy patches, model: PR6001, PR5001Light Tree Ventures Europe B.V.202318—
+9K231215IPL Hair Removal Device Model: Skin Expert Pro IPL 008, Skin Expert Pro IPL 008SZhongshan Qizhe Technology Co., Ltd.20230—
+9K223033Tixel® 2 SystemNovoxel, Ltd.20230—
+9K223147myLEDmaskMyblend20234—
+9K230816Intense Pulsed Light Treatment SystemShangdong Huamei Technology Co., Ltd.20231—
+9K230360IPL Cooling Hair Removal Device, Model (s): NBB01, NBB02Shenzhen Jizhimei Technology Co., Ltd.202317—
+9K230021IPL Hair Removal Device, Model (s): AP10, AP20, AP30, AP32Shenzhen Yangyi Technology ., Ltd.20236—
+9K230060Light Based Hair Removal Device GP592Shenzhen Gsd Tech Co., Ltd.20230—
+9K222685NIRA Model 2Dermal Photonics Corp20230—
+9K222673Alexandrite and Nd:YAG Laser models CANLASE and TORLASECanadian Pioneer Medical Technology Corporation (Cpmt Laser)20220—
+9K221574LUDWIG Electrosurgical DeviceAesthetics Biomedical20220—
+9K213120OW100S (model OW100S-US)Tissue Regeneration Technologies, LLC Dba AS Softwave Trt20220—
+9K212561MTX-C1Ilooda Co,., Ltd.20220—
+9K213674CellFX SystemPulse Biosciences, Inc.20220—
+9K222075CellFX SystemPulse Biosciences, Inc.20220—
+9K221189Oliz LTB-1000ALtbio Co., Ltd.20220—
+9K220268Picosecond Laser System (Model PS10-A and PS10-B)Beijing Adss Development Co., Ltd.20221—
+9K220385Intense Pulsed Light EquipmentBeijing Globalipl Development Co., Ltd.20220—
+9K221789IRIS Pi Q switched Nd YAG laserBio-Med USA, Inc.20220—
+9K221451IPL hair removalShenzhen Lizbella Technology Co.,Ltd20220—
+9K221671CellFX® SystemPulse Biosciences, Inc.20220—
+9K221430reVive Light Therapy LED Cleansing SystemLed Technologies, Inc.20220—
+9K212073Alma Diode Tabletop LaserAlma Lasers, Ltd.20220—
+9K221083Smartlux MiniMedmix Co., Ltd.20222—
+9K221246IPL Hair Removal (Model: SL-B080, SL-B126, SL-B136)Shenzhen Semlamp Intelligent Technology Co., Ltd.20220—
+9K212663Helios IV 785Laseroptek Co., Ltd.20223—
+9K220729The Luminance RED Acne DeviceLuminance Medical Ventures, Inc.20221—
+9K210084SilkroHironic Co., Ltd.20223—
+9K210545Infrared Red blue LED light heat beauty machine, Infrared Red blue LED light heat beauty…Marci Beauty, Inc.20222—
+9K221001IPL Home Use Hair Removal DeviceShenzhen Beauty Every Moment Intelligent Electric Co., Ltd.20226—
+9K220592Venus BlissMAXVenus Concept USA, Inc.20221—
+9K213889PicoStarAsclepion Laser Technologies GmbH20220—
+9K213534PHantom TrilogyResurgeonz, LLC20220—
+9K210367D-Laser Blue, D-Laser 16Guilin Woodpecker Medical Instrument Co., Ltd.20226—
+9K220124YandR System, VoluDerm Handpiece, VoluDerm TipsPollogen, Ltd.20220—
+9K213830Home use hair removal device, model: Precise Touch ProIluminage Beauty Co., Limited20220—
+9K213841ENEO TOTALE (Model: ENEOT947)Premier North America, Inc.20222—
+9K210968reVive Light Therapy EssentialsLed Technologies, Inc.20213—
+9K202848S2 Pigment Removal SystemLightsense Technologies, Ltd.20210—
+9K212107ReversoIntelis Instruments, Ltd.20211—
+9K212897IPL Hair Removal Device, model: AI01Shenzhen Century Dongyuan Technology CO, Ltd.20211—
+9K212314IPL Hair Removal DeviceZhongshan Bisen Plastic Electronic Products Co., Ltd.202123—
+9K210376Superior Hair RemoverGuangzhou Haoxingwan Technology Co., Ltd.20210—
+9K212082PicoreBio-Med USA, Inc.20210—
+9K211922IPL Home Use Hair Removal DeviceShenzhen Beauty Every Moment Intelligent Electric Co., Ltd.20210—
+9K202780SectumNeauvia North America20211—
+9K210311Home Use IPL Beauty Device, Model (s): MS-208B, MS-212B, MS-216B, MS-218B, MELSYA-M6…Shenzhen Mismon Technology Co., Ltd.202124—
+9K200983Infrared light therapy led facial light therapy mask-Derma plus, Photons Facial Skin…Ningbo Hesi Electric Co., Ltd.202146—
+9K211821DEKA Motus AZEl.En Electronic Engineering Spa20211—
+9K211272ICOONE Laser Med (also referred to as ICOONE Medical laser)I-Tech Industries Srl20211—
+9K202055Looper (Model: ZX-579S)Heat IN A Click, LLC20213—