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
+10K241951Lasya-TrinityBLUECORE COMPANY Co., Ltd.20240—
+10K241933HIGHERDOSE Red and Infrared Light Mask (MK66-L)Shenzhen Kaiyan Medical Equipment Co., Ltd.20241—
+10K242202LightWalker Laser System FamilyFotona D.O.O.20241—
+10K241102Luna 4 plusForeo, Inc.20245—
+10K233123SilkroHironic Co., Ltd.20241—
+10K241407Splendor X (Alex, Alex2, Nd:YAG, Alex+Nd:YAG)Bios S.R.L.20240—
+10K233120CWM-930S, Fixer DV9Chungwoo Co., Ltd.20240—
+10K233099GladiatorRohrer Aesthetics, LLC20240—
+10K240386Picosecond Nd:YAG Laser Systems (BL-C10)Shanghai Bele Medical Technology Co.,Ltd20240—
+10K240999Legend X Applicator VOPollogen, Ltd.20241—
+10K233157VaporMAX LDD; MOJo LDD; MegaJOULE LDDInnovaquartz, LLC20240—
+10K233849BTL-499BTL Industries, Inc.20240—
+10K232133Co2 Laser System, Models: PureLase And VanLaseCpmt Laser (Canadian Pioneer Medical Technology Corporation)20240—
+10K240360Wrinkle Treatment Device (JM2)Shenzhen Qianyu Technology Co., Ltd.20242—
+10K233604BTL-785SBTL Industries, Inc.20243—
+10K230837PlazMagikAgnes Medical Co., Ltd.20240—
+10K231896Diode Laser Therapy SystemBeijing Adss Development Co., Ltd.20240—
+10K233143PiXel8-RevealRohrer Aesthetics20240—
+10K233224Epilaser ProEpilady 2000, LLC20240—
+10K232106Air Gap FiberWontech Co., Ltd.20240—
+10K232708Intense pulsed light therapy deviceHebei Zhemai Technology Co., Ltd.20230—
+10K232222Primo Dental Laser (Primo, Primo Komfort, Primo Lite, Primo Blue, and Primo Triplo)Medency S.R.L.20230—
+10K233147PiXel8-RFRohrer Aesthetics20230—
+10K232223PlaDuo SystemShenB Co., Ltd.20230—
+10K223919B.Light Clear Evo and B.Light Restore EvoBemer Int AG20232—
+10K231790The InMode System with the Morpheus8 ApplicatorsInMode, Ltd.202310—
+10K223871Miria Skin Treatment SystemAVAVA, Inc.20232—
+10K222790F65 Laser SystemLumenis Be, Ltd.20233—
+10K230373HELIOS 785 PicoLaseroptek Co., Ltd.20232—
+10K222221Deka HelixEl.En Electronic Engineering Spa20231—
+10K220853PicoWay Laser SystemCandela Corporation20221—
+10K221770Fiber Laser Treatment SystemShanghai Apolo Medical Technology Co., Ltd.20221—
+10K214015Palm NRG cellulite body device (model: Palm NRG body device)Heat IN A Click, LLC20220—
+10K221597CO2 Laser SystemSmedtrum Medical Technology Co., Ltd.20222—
+10K221427V-LaserWontech Co., Ltd.20222—
+10K212472AgeJetTriworks Group Srl20220—
+10K211000AcutronIlooda Co,., Ltd.20220—
+10K220168Skin Care Beauty Mask (Model: MJ-06)Shenzhen Kaiyan Medical CO, Ltd.202234—
+10K220189LISA Laser Surgical FibersOmni-Guide Holdings, Inc.20225—
+10K210367D-Laser Blue, D-Laser 16Guilin Woodpecker Medical Instrument Co., Ltd.20226—
+10K212127PicocaremajestyWontech Co., Ltd.20226—
+10K201773PicohiHironic Co., Ltd.20215—
+10K211821DEKA Motus AZEl.En Electronic Engineering Spa20211—
+10K203491PicoLO Nd: YAG Picosecond Laser SystemLaseroptek Co., Ltd.20211—
+10K201171LEONI Laser Fibers: BareFiber Disposable, BareFiber Reusable and Endoprobe DisposableLeoni Fiber Optics, Inc.20210—
+10K202827308nm Excimer UV-light Skin Therapy SystemShenzhen Gsd Tech Co., Ltd.20200—
+10K200693K2 MobileHulaser, Inc.20202—
+10K202041Opera EvoQuanta System Spa20200—
+10K200116PicoSecond Nd: YAG Laser SystemShanghai Apolo Medical Technology Co., Ltd.20206—
+10K193486Epic 980Biolase, Inc.20202—
+10K200234Surgical laser fibersQuanta System Spa20202—
+10K191855EmFace DeviceInmode MD, Ltd.20191—
+10K181614Sterling Supreme Diode LaserCAO Group, Inc.20190—
+10K191162EpiLaze Multi-wavelength LaserRohrer Aesthetics, LLC20190—
+10K181095RF-ReliefEl Global Trade, Ltd.20181—
+10K180044SIROLaser BlueDentsply Sirona201812—
+10K173677InMode VLazeInmode MD, Ltd.20183—
+10K172302InMode PLUS SystemInmode MD, Ltd.201713—
+10K171711Thunder, Thunder VT, Thunder HRQuanta System Spa20170—
+10K163197Cook Holmium Laser FiberCook Incorporated20170—
+10K163128Epic ProBiolase, Inc.201716—
+10K163222Discovery Pico FamilyQuanta System Spa201630—
+10K162781Magma SparkFormatk Systems, Ltd.20160—
+10K161356Matrix LS-40 CO2 Laser SystemShanghai Wonderful Opto-Electrics Tech.Co.,Ltd20160—
+10K160513Quanta System Surgical Laser fibersQuanta System Spa201631
+10K152417Adler MicroMed Laser Surgery FibersAdler Micromed, Inc.20153—
+10K122020Photon Photon PlusZolar Technology & Mfg Co., Inc.20134—
+11K261370LED Light Therapy Masks (LED Face Mask Pulse (FAC06NA))Guangdong Newdermo Biotech Co., Ltd.20260—
+11K254185Potenza PrimeJeisys Medical Incorporated20260—
+11K2618211565nm Laser Therapy Device (PZ-JG86-01,PZ-JG86-02)Zhengzhou PZ Laser Slim Technology Co., Ltd.20260—
+11K253859Scarlet Pro (Scarlet Pro)VIOL Co., Ltd.20260—
+11K261601LED Light Therapy Mask (M01, M02, M03, M05, M06, M07, M08)Shenzhen Chuangtong Yigou Technology Co., Ltd.20260—
+11K253484Lutronic GeniusCynosure Lutronic Technology Corporation20260—
+11K261052LED Light Therapy Masks (LED Face Mask Pro FAC08NA, LED Chest Mask Pro FAC09NA)Guangdong Newdermo Biotech Co., Ltd.20260—
+11K260946LED Light Therapy Mask (K9C-TK, K9C-K, K9P-YK, K9P-K, FM-03BK, FM-09K)Guangdong Newdermo Biotech Co., Ltd.20260—
+11K253803MILAN SystemLumenis Be, Ltd.20260—
+11K253309SOGA Lasers therapy system family of Aurora handpiece (Aurora-S); SOGA Lasers therapy…Shenzhen Soga Technology Co., Ltd.20260—
+11K261214Pico Shining (Pico-K; Picofy)Speclipse, Inc.20260—
+11K260150Led Facial Mask (MJ-66DB, MK-99, MK-99A, MK-99M, MJ-66C)Nooance20260—
+11K260017Picosecond Nd:YAG Laser Systems (Model: HS-298)Shanghai Apolo Medical Technology Co., Ltd.20260—
+11K253750BTL-785NEHBTL Industries, Inc.20260—
+11K254079LED Light Therapy Mask (Models: T2, RLD10)Shenzhen Desida Technology Co., Ltd.20260—
+11K253829Medical Ultra-Pico Laser Treatment System (CM-SP-1064&532)Beijing HuaCheng Taike Technology Co., Ltd.20260—
+11K251435InbellaIgnite RF SystemInbella Medical, Inc.20260—
+11K252753Vydence Family of LasersVydence Medical Industria E Commercio Ltda20260—
+11K253712LED Light Therapy Mask (RB-051, RB-061, RB-071, RB-052, RB-062, RB-072, RB-053, RB-063…Shenzhen Rainbow Technology Co., Ltd.20261—
+11K251254Ignite RF SystemInMode, Ltd.20260—
+11K253086LED Light Therapy Device (Models: SG-FM, SG-FE)Sunglor Technology Co., Ltd.20250—
+11K252264MEGELIN LED Light Therapy Mask (JML1, JML1+JML2); MEGELIN LED Light Therapy Mask (JML3…Shenzhen Zhenxing Ruitong Technology Co., Ltd.20252—
+11K250731MateLaser Medical Diode Laser Systems (ML-DLS-30)Matelaser, Inc.20250—
+11K252093Light Therapy Mask (1019055)Merchsource, LLC20250—
+11K252367InbellaMulti SystemInbella Medical, Inc.20250—
+11K252447Picosecond laser device (BMPS4)Hebei Newangie Technology Co., Ltd.20250—
+11K251334New Doublo 2.0Hironic Co., Ltd.20250—
+11K250734OptiLUV DevicePollogen, Ltd.20250—
+11K251031Fiber Laser Treatment Systems (HS-232,HS-233)Shanghai Apolo Medical Technology Co., Ltd.20250—
+11K250880Led Light Mask (A093)Foshan Guangyu Weilai Medical Equipment Co., Ltd.20250—
+11K250581KALA Red Light Face Mask (KALA-01)Shenzhen Kaiyan Medical Equipment Co., Ltd.20250—
+11K250041Medical Picosecond ND: YAG Laser System (PZ-6)Zhengzhou PZ Laser Slim Technology Co., Ltd.20250—
+11K243764Medical Diode Laser (UTU3-F7B,UTU3-F7W,UTU3-G7B,UTU3-G7W,UTU-G20B,UTU-G20W)Wuhan Pioon Technology Co., Ltd.20250—