510(k) Report

Devices descending from K961748

1,230 later devices reach Medlite/Erbium Laser System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+8K250761KALA Therapy Wand (Model: KALA-03)Shenzhen Kaiyan Medical Equipment Co., Ltd.20251—
+8K243123IPL Treatment Device (MDSQMC-01)Medusa (Guangxi)Medical Devices Co., Ltd.20250—
+8K251031Fiber Laser Treatment Systems (HS-232,HS-233)Shanghai Apolo Medical Technology Co., Ltd.20250—
+8K251329Diode laser device (RF3120-BI)Risu Medical Technology Co., Ltd.20252—
+8K250782Fractional CO2 Laser MachineZhengzhou PZ Laser Slim Technology Co., Ltd.20250—
+8K240983Discovery Pico; Discovery Pico Plus; Discovery Pico DermQuanta System Spa20251—
+8K251230The Alma Hybrid Laser SystemAlma Lasers, Inc.20250—
+8K243896LenSx Laser System (8065998162)Alcon Laboratories, Inc.20251—
+8K250206Diode laser system (Night Universe; Predator)Ivylaser (Beijing) Technology Co.,Ltd20250—
+8K250809Stellar M22Lumenis Be, Ltd.20250—
+8K242151Radiant Renewal Skincare Wand (HD-44,HD-44A ,HD-44B,HD-44C, HD-69, HD-69A, HD-69B)Shenzhen Nuon Medical Equipment Co., Ltd.20251—
+8K250125LMNT O2Xplr, Ltd.20250—
+8K244022308nm UV Phototherapy System (UV-K); 308nm UV Phototherapy System (UV-X); 308nm UV…Boston Aesthetics, Inc.20250—
+8K241832Unicorn+ RF System (Unicorn+); Unicorn+ RF System (Unicorn+ I); Unicorn+ RF System…Boston Aesthetics, Inc.20251—
+8K243488Vmat ProTermosalud20250—
+8K243430Micro-current Facial Beauty Device (AM-810B, AM-810W, AM-812B, AM-812W)Shenzhen Aozemei Technology Co., Ltd.20243—
+8K242440Intense Pulsed Light Treatment System (LK-PT)Nanjing Bestview Laser S&T Co., Ltd.20240—
+8K242183Fractional CO2 Laser Therapy System (EXFU CO2)Weifang Mingliang Electronics Co., Ltd.20240—
+8K241092Youlaser PRIME; Youlaser PRIME CO2; Youlaser PRIME MTQuanta System Spa20240—
+8K242206ActivoDaeju Meditech Engineering Co., Ltd.20240—
+8K241102Luna 4 plusForeo, Inc.20245—
+8K241656Eneka SelectifTermosalud20241—
+8K241600DermablateAsclepion Laser Technologies GmbH20240—
+8K240611IVYLASER Diode laser hair removal system (IVY-HR-Alloy)Ivylaser (Beijing) Technology Co.,Ltd20240—
+8K240222Dermalux Tri-Wave MD MKII (1000021); Dermalux Compact MD (1000024)Aesthetic Technology, Ltd.20240—
+8K240482Intense Pulsed Light System (ST-690)Smedtrum Medical Technology Co., Ltd.20241—
+8K240816MeDioStarAsclepion Laser Technologies GmbH20240—
+8K222958mJOULE RF System and AccessoriesSciton, Inc20240—
+8K233757TitanPico Laser Workstation (PICO-450)Rhein Laser Technologies Co., Ltd.20240—
+8K240132EmoLED (v. 2-USA)Emoled, Srl20240—
+8K233224Epilaser ProEpilady 2000, LLC20240—
+8K233550MOSAIC 3D (Surgical Laser)Lutronic Aesthetic20240—
+8K232977Biophotas Celluma CONTOURBiophotas, Inc.20235—
+8K232656BLU TOTALE (Model: ENEOB852)Premier North America, Inc.20232—
+8K233090DEKA AGAIN PRO familyEl.En S.P.A.20232—
+8K230490PMD Clean Acne, Model: 4004-CABLUE-NA, 4004-GREY-NA, 4004-YELLOW-NA, 4004-PSTO-NA…Dongguan Hunter Electronic Technology Co., Ltd.20230—
+8K230013Silk'n Titan AllwaysSilk'N Beauty, Ltd.20230—
+8K231054V-LaserWontech Co., Ltd.20231—
+8K222862SILKPRO Titanium Diode Laser System SILKPRO-S20S-TWCLotuxs Medtech (Suzhou) Co., Ltd.20231—
+8K231555LUMA LED patches (LUMA Blemish (TN2197) and LUMA Revive (TN2189))iSMART Developments, Ltd.20231—
+8K230720LUSTRE 3XPRESS Light Beauty Therapy patches, model: PR6001, PR5001Light Tree Ventures Europe B.V.202318—
+8K223871Miria Skin Treatment SystemAVAVA, Inc.20232—
+8K222790F65 Laser SystemLumenis Be, Ltd.20233—
+8K222556BTL-785XBTL Industries, Inc.20235—
+8K230580Diode Laser SystemSmedtrum Medical Technology Co., Ltd.20230—
+8K223147myLEDmaskMyblend20234—
+8K230816Intense Pulsed Light Treatment SystemShangdong Huamei Technology Co., Ltd.20231—
+8K221865BTL-094BTL Industries, Inc.20230—
+8K230371The Alma Soprano TitaniumAlma Lasers, Inc.20232—
+8K222685NIRA Model 2Dermal Photonics Corp20230—
+8K210166Omnispec ED1000Medispec, Ltd.20230—
+8K223540AvalancheLase FamilyFotona D.O.O.20230—
+8K222221Deka HelixEl.En Electronic Engineering Spa20231—
+8K223647CLEAR+BRILLIANT TOUCH® Laser SystemSolta Medical, Inc.20220—
+8K221574LUDWIG Electrosurgical DeviceAesthetics Biomedical20220—
+8K221770Fiber Laser Treatment SystemShanghai Apolo Medical Technology Co., Ltd.20221—
+8K213267Dynamis Pro FamilyFotona D.O.O.20222—
+8K221189Oliz LTB-1000ALtbio Co., Ltd.20220—
+8K220385Intense Pulsed Light EquipmentBeijing Globalipl Development Co., Ltd.20220—
+8K221430reVive Light Therapy LED Cleansing SystemLed Technologies, Inc.20220—
+8K212073Alma Diode Tabletop LaserAlma Lasers, Ltd.20220—
+8K221083Smartlux MiniMedmix Co., Ltd.20222—
+8K220538DolorClast RadialE.M.S Electro Medical Systems S.A20221—
+8K212663Helios IV 785Laseroptek Co., Ltd.20223—
+8K220729The Luminance RED Acne DeviceLuminance Medical Ventures, Inc.20221—
+8K220259ALLY Adaptive Cataract Treatment SystemLensar, Inc.20220—
+8K213332Multifrax Laser SystemParadigm Medical Corporation20220—
+8K210084SilkroHironic Co., Ltd.20223—
+8K210545Infrared Red blue LED light heat beauty machine, Infrared Red blue LED light heat beauty…Marci Beauty, Inc.20222—
+8K213559FEMTO LDV Z8 Femtosecond Surgical LaserSie Ag,Surgical Instrument Engineering20221—
+8K213534PHantom TrilogyResurgeonz, LLC20220—
+8K220124YandR System, VoluDerm Handpiece, VoluDerm TipsPollogen, Ltd.20220—
+8K213841ENEO TOTALE (Model: ENEOT947)Premier North America, Inc.20222—
+8K210968reVive Light Therapy EssentialsLed Technologies, Inc.20213—
+8K212492Frax 1940 for Nordlys and Frax ProCandela Corporation20210—
+8K202848S2 Pigment Removal SystemLightsense Technologies, Ltd.20210—
+8K200983Infrared light therapy led facial light therapy mask-Derma plus, Photons Facial Skin…Ningbo Hesi Electric Co., Ltd.202146—
+8K210451OrthoGold 100Tissue Regeneration Technologies, LLC20212—
+8K202055Looper (Model: ZX-579S)Heat IN A Click, LLC20213—
+8K210226PicoSure WorkstationCynosure, LLC20213—
+8K203788DermaV Laser SystemLutronic Corporation202101
+8K202985LightWalker Laser System FamilyFotona D.O.O.20217—
+8K201685PotenzaJeisys Medical, Inc.20219—
+8K202028dermalux Flex MDAesthetic Technology, Ltd.20205—
+8K200971308nm Excimer SystemXuzhou Kernel Medical Equipment Co., Ltd.20201—
+8K202827308nm Excimer UV-light Skin Therapy SystemShenzhen Gsd Tech Co., Ltd.20200—
+8K201735PlaDuo SystemShenB Co., Ltd.20203—
+8K200724VICTUS Femtosecond Laser PlatformTechnolas Perfect Vision GmbH20200—
+8K201109CO2 Laser Therapy SystemShanghai Apolo Medical Technology Co., Ltd.20205—
+8K200947InMode System with the Morhpeus8 ApplicatorsInMode, Ltd.202015—
+8K201111GentleMax Pro PlusCandela Corporation20203—
+8K192642308nm Excimer SystemChongqing Peninsula Medical Technology Co., Ltd.20202—
+8K192295PDT-FaceBeijing Adss Development Co., Ltd.202046—
+8K192951Ellipse Frax 1940 for Ellipse Nordlys and Ellipse YdunEllipse A/S20201—
+8K193328IPL + Diode Laser MachineBeijing Globalipl Development Co., Ltd.20200—
+8K193661LightWalker Laser System FamilyFotona D.O.O.20208—
+8K200110SANDRO DualWontech Co., Ltd.20202—
+8K192583PicoLazer Laser SystemRohrer Aesthetics, LLC20200—
+8K191086ExciplexClarteis20194—
+8K192519Multi-modality workstationBeijing Superlaser Technology Co., Ltd.20192—