510(k) Report

Devices descending from K910422

1,503 later devices reach Model RD-1200 Ruby Laser System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+9K250761KALA Therapy Wand (Model: KALA-03)Shenzhen Kaiyan Medical Equipment Co., Ltd.20251—
+9K250942Ice Cooling IPL Hair Removal Device (UI20S DB, UI20S RE, UI20S PW, UI20S GP, UI20S GR…Shenzhen Ulike Smart Electronics Co., Ltd.20253—
+9K250065DENSITY; DENZA; DENSITY NoirJeisys Medical Incorporated20250—
+9K243123IPL Treatment Device (MDSQMC-01)Medusa (Guangxi)Medical Devices Co., Ltd.20250—
+9K251049SurgiLight 1470 Diode Laser System (Model:Halo)Micro-Energy Medical Technology Co., Ltd.20250—
+9K251000Hand-held Hair Removal Device (FZ-200A, FZ-201, FZ-202, CT05, CT06, CT07, CT08, CT09)Shenzhen Chuangtong Yigou Technology Co., Ltd.20251—
+9K243036IPL Hair Removal Device (BHRL-01, BHRL-02, BHRL-03, BHRL-04, BHRL-05, BHRL-06, BHRL-06B…Bestway Plastic and Metal Products, Ltd.20251—
+9K250782Fractional CO2 Laser MachineZhengzhou PZ Laser Slim Technology Co., Ltd.20250—
+9K240983Discovery Pico; Discovery Pico Plus; Discovery Pico DermQuanta System Spa20251—
+9K251230The Alma Hybrid Laser SystemAlma Lasers, Inc.20250—
+9K250809Stellar M22Lumenis Be, Ltd.20250—
+9K250402AVAVA™ Skin Treatment SystemAVAVA, Inc.20251—
+9K242151Radiant Renewal Skincare Wand (HD-44,HD-44A ,HD-44B,HD-44C, HD-69, HD-69A, HD-69B)Shenzhen Nuon Medical Equipment Co., Ltd.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—
+9K242977308nm Excimer Phototherapy Device (CN-308E, KN-4003B3, KN-4003B4, KN-5000C KN-5000D…Xuzhou Kernel Medical Equipment Co., Ltd.20250—
+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—
+9K241998Ice Cooling IPL Hair Removal Device (UI20 DB, UI20 RE, UI20 GP, UI20 PW, UI20S DB, UI20S…Shenzhen Ulike Smart Electronics Co., Ltd.20246—
+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—
+9K241092Youlaser PRIME; Youlaser PRIME CO2; Youlaser PRIME MTQuanta System Spa20240—
+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—
+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—
+9K240093IPL Home Use Hair Removal Device (SJ15)Shenzhen Shuge Medical Beauty Devices Co., Ltd.20240—
+9K240816MeDioStarAsclepion Laser Technologies GmbH20240—
+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—
+9K233090DEKA AGAIN PRO familyEl.En S.P.A.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—
+9K222790F65 Laser SystemLumenis Be, Ltd.20233—
+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—
+9K222221Deka HelixEl.En Electronic Engineering Spa20231—
+9K221574LUDWIG Electrosurgical DeviceAesthetics Biomedical20220—
+9K221770Fiber Laser Treatment SystemShanghai Apolo Medical Technology Co., Ltd.20221—
+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—
+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—
+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—