510(k) Report

Devices descending from P910001

767 later devices reach Spectranectics CVX-300 Excimer Laser System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+9K243223Multiple therapy aesthetic treatment device (BHS 202 UNYQUE)Bh Group Us, LLC20260—
+9K261673LED Therapy Device (QLXY-01)Beijing Nubway S&T Co., Ltd.20260—
+9K261562Diode Laser Therapy SystemSanhe LEFIS Electronics Co., Ltd.20260—
+9K254025LED Neck Beauty Mask (ZLD-66A,ZLD-90E,ZLD-130,ZLD-180H)Shenzhen Kaiyan Medical Equipment Co., Ltd.20260—
+9K253251Leaseir MHR Xcell (console) (MHR-100b); Handpiece: Dual (810-b and Blend-b); Handpiece…Leaseir Technologies, Slu20260—
+9K260129Lumaflex Panel (ZLD-05, ZLD-05A, ZLD-05APro )Shenzhen Kaiyan Medical Equipment Co., Ltd.20261—
+9K253833Facial & Body Beauty Device (model: INIA-BD001, INIA-BD002, INIA-BD003, INIA-BD004…Shenzhen Jianchao Intelligent Technology Co., Ltd.20260—
+9K251988Boston iFace (Boston iFace)Boston Aesthetics, Inc.20260—
+9K252187Aura Glide (FC40)Aura Medical, LLC20250—
+9K251077JOULE 1064nm System and AccessoriesSciton, Inc20250—
+9K252994LED Therapy Mask (SR11CM, SR11CM1, SR11CM2, SR11CM3, SR11CM4, SR11CM5, SR11CM6, SR11CM7…Guangdong Ace-Tec Co., Ltd.20250—
+9K251825Jmoon FlexGlow Light Therapy Device (JD20U SP, JD20U SG)Shenzhen Ulike Smart Electronics Co., Ltd.20250—
+9K252063Medical Diode Laser Systems (BERYLAS-12N); Medical Diode Laser Systems (BERYLAS-15N)…Wuhan Dimed Laser Technology Co., Ltd.20250—
+9K242859VEGAIbramed Equipamentos Médicos20250—
+9K251781Kala Mini 2.0 (Kala-04)Shenzhen Kaiyan Medical Equipment Co., Ltd.20250—
+9K251667LED Light Therapy Mask (M01, M02, M06, M07, M08, M09)Shenzhen Liyoutong Technology Co., Ltd.20250—
+9K251329Diode laser device (RF3120-BI)Risu Medical Technology Co., Ltd.20252—
+9K250782Fractional CO2 Laser MachineZhengzhou PZ Laser Slim Technology Co., Ltd.20250—
+9K240983Discovery Pico; Discovery Pico Plus; Discovery Pico DermQuanta System Spa20251—
+9K251042Light Therapy System (M500, L6)Guangzhou Ahead Intelligent Technology Co., Ltd.20251—
+9K250206Diode laser system (Night Universe; Predator)Ivylaser (Beijing) Technology Co.,Ltd20250—
+9K241947EnergyLounger (TY-01)Shenzhen Kaiyan Medical Equipment Co., Ltd.20251—
+9K242593CurrentBody™ LED 4 in 1 Zone Facial Mapping Mask (MK-90C, MK-90M, MK66RB-F, MK-90N)Shenzhen Kaiyan Medical Equipment Co., Ltd.20253—
+9K241832Unicorn+ RF System (Unicorn+); Unicorn+ RF System (Unicorn+ I); Unicorn+ RF System…Boston Aesthetics, Inc.20251—
+9K243393JMOON NouvelleSkin Facial Toning Device (M30U PR, M30U MW, M30U SG, M30U SK, M30U MP)Shenzhen Ulike Smart Electronics Co., Ltd.20251—
+9K243492Ulike Reglow Light Therapy Device (UM10)Shenzhen Ulike Smart Electronics Co., Ltd.20253—
+9K242789Bestqool LED Therapy Device (LMK-001,LMK-004,LMK-005,LMK-006)Dongguan Laiguang Electronic Technology Co., Ltd.20253—
+9K243430Micro-current Facial Beauty Device (AM-810B, AM-810W, AM-812B, AM-812W)Shenzhen Aozemei Technology Co., Ltd.20243—
+9K242700Radiant Renewal Skincare Lid (HD-59A, HD-59B, HD-59C, HD-59D, HD-70, HD-72, HD-72A…Shenzhen Nuon Medical Equipment Co., Ltd.20246—
+9K242440Intense Pulsed Light Treatment System (LK-PT)Nanjing Bestview Laser S&T Co., Ltd.20240—
+9K241718Micro-current Facial Beauty Device (AM-810B, AM-810W, AM-812B, AM-812W)Shenzhen Aozemei Technology Co., Ltd.202412—
+9K242183Fractional CO2 Laser Therapy System (EXFU CO2)Weifang Mingliang Electronics Co., Ltd.20240—
+9K242206ActivoDaeju Meditech Engineering Co., Ltd.20240—
+9K241656Eneka SelectifTermosalud20241—
+9K241203PMD Clean Redvolution (4005-moab-NA, 4005-moab-INT, 4005-pepper-NA, 4005-pepper-INT…Dongguan Hunter Electronic Technology Co., Ltd.20240—
+9K241293LED Light Therapy Device, ELIXIR MD™Yassen Wellness, LLC20247—
+9K241600DermablateAsclepion Laser Technologies GmbH20240—
+9K240611IVYLASER Diode laser hair removal system (IVY-HR-Alloy)Ivylaser (Beijing) Technology Co.,Ltd20240—
+9K240482Intense Pulsed Light System (ST-690)Smedtrum Medical Technology Co., Ltd.20241—
+9K240816MeDioStarAsclepion Laser Technologies GmbH20240—
+9K222958mJOULE RF System and AccessoriesSciton, Inc20240—
+9K233757TitanPico Laser Workstation (PICO-450)Rhein Laser Technologies Co., Ltd.20240—
+9K240396Elite iQ PRO (M122K1)Cynosure, LLC20240—
+9K233077FlashHeal 2 (FlashHeal 2.0)Inwound Aps20240—
+9K232863Radiant Renewal Skincare Wand (HD-15, HD-15A)Shenzhen Kaiyan Medical Equipment Co., Ltd.20230—
+9K233090DEKA AGAIN PRO familyEl.En S.P.A.20232—
+9K232236EchoQuanta System Spa20230—
+9K231894LED Spectrum therapy instrumentShenzhenshi Sincoheren S&T Development Co., Ltd.20230—
+9K231054V-LaserWontech Co., Ltd.20231—
+9K222862SILKPRO Titanium Diode Laser System SILKPRO-S20S-TWCLotuxs Medtech (Suzhou) Co., Ltd.20231—
+9K230293TheraFace MaskTherabody, Inc.202316—
+9K222556BTL-785XBTL Industries, Inc.20235—
+9K230580Diode Laser SystemSmedtrum Medical Technology Co., Ltd.20230—
+9K230816Intense Pulsed Light Treatment SystemShangdong Huamei Technology Co., Ltd.20231—
+9K223544LED light therapy mask (FM-01, FM-02, FM-03)Guangdong Newdermo Biotech Co., Ltd.202339—
+9K230371The Alma Soprano TitaniumAlma Lasers, Inc.20232—
+9K223540AvalancheLase FamilyFotona D.O.O.20230—
+9K213105Epilaser AbsoluteEpilady 2000, LLC20221—
+9K221268SR-1 Skin Treatment SystemAVAVA, Inc.20223—
+9K221574LUDWIG Electrosurgical DeviceAesthetics Biomedical20220—
+9K213267Dynamis Pro FamilyFotona D.O.O.20222—
+9K220385Intense Pulsed Light EquipmentBeijing Globalipl Development Co., Ltd.20220—
+9K220064Synergy Marble (Model: Opasm)Yrs Group, Inc.20220—
+9K212073Alma Diode Tabletop LaserAlma Lasers, Ltd.20220—
+9K212663Helios IV 785Laseroptek Co., Ltd.20223—
+9K210084SilkroHironic Co., Ltd.20223—
+9K210545Infrared Red blue LED light heat beauty machine, Infrared Red blue LED light heat beauty…Marci Beauty, Inc.20222—
+9K213350mJOULE System and AccessoriesSciton, Inc20220—
+9K220124YandR System, VoluDerm Handpiece, VoluDerm TipsPollogen, Ltd.20220—
+9K212155TheraFace LEDTheragun, Inc.202142—
+9K202848S2 Pigment Removal SystemLightsense Technologies, Ltd.20210—
+9K212275Dermalux Flex MDAesthetic Technology, Ltd.20214—
+9K212238TheraFace MicrocurrentTheragun, Inc.20210—
+9K202390Aduro Light Beauty MaskShenzhen Kaiyan Medical CO, Ltd.202139—
+9K203441The Alma Hybrid Laser SystemAlma Lasers, Ltd.20215—
+9K210226PicoSure WorkstationCynosure, LLC20213—
+9K203788DermaV Laser SystemLutronic Corporation202101
+9K202985LightWalker Laser System FamilyFotona D.O.O.20217—
+9K201685PotenzaJeisys Medical, Inc.20219—
+9K201735PlaDuo SystemShenB Co., Ltd.20203—
+9K202172StarWalkerFotona D.O.O.20203—
+9K201109CO2 Laser Therapy SystemShanghai Apolo Medical Technology Co., Ltd.20205—
+9K200947InMode System with the Morhpeus8 ApplicatorsInMode, Ltd.202015—
+9K200786Venus EpileveVenus Concept USA, Inc.20200—
+9K192350Medical Non-Ablative Fractional Laser SystemsWingderm Electro-Optics, Ltd.202021
+9K193328IPL + Diode Laser MachineBeijing Globalipl Development Co., Ltd.20200—
+9K193661LightWalker Laser System FamilyFotona D.O.O.20208—
+9K192583PicoLazer Laser SystemRohrer Aesthetics, LLC20200—
+9K193500Stellar M22 for Intense Pulsed Light (IPL) and Laser SystemLumenis, Ltd.202012—
+9K192430Epic 980Biolase, Inc.20195—
+9K192519Multi-modality workstationBeijing Superlaser Technology Co., Ltd.20192—
+9K191685PicoWay Laser SystemCandela Corporation201920—
+9K181602Pioneer Elite Diode LaserCAO Group, Inc.20190—
+9K181601Precise SHP Diode LaserCAO Group, Inc.20191—
+9K182355Secret RF Smartcure Applicator with electrodesIlooda Co,., Ltd.20191—
+9K191349980nm Diode Laser Therapy DeviceShanghai Apolo Medical Technology Co., Ltd.20190—
+9K191611Diode Laser Therapy SystemsWingderm Electro-Optics, Ltd.201901
+9K183156V-LaserWontech Co., Ltd.20193—
+9K183392PicoLO Nd:YAG Picosecond Laser SystemLaseroptek Co., Ltd.20192—
+9K182997enlighten III Laser SystemCutera, Inc.20180—