510(k) Report

Devices descending from K853620

676 later devices reach Model XA-50 - CO2 Surgical Laser through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K213761Joule diVa SystemSciton, Inc20220—
+5K221571InMode Multi-systemInMode, Ltd.20222—
+5K211979Lumenis Y&R Laser SystemLumenis, Inc.20220—
+5K211652Renuvion Dermal Handpiece, Renuvion Dermal SystemApyx Medical Corporation (Formerly Bovie Medical Corporation20220—
+5K220467The Family of UltraPulse CO2 Surgical and Aesthetic Lasers, Delivery Devices and…Lumenis Be, Ltd.20220—
+5K201520The Alma Opus System, Colibri Applicator and TipsAlma Lasers, Inc.20211—
+5K203441The Alma Hybrid Laser SystemAlma Lasers, Ltd.20215—
+5K203299CellFX SystemPulse Biosciences, Inc.20214—
+5K201064V30 System, V20 System, V10 System, V-FR HandpieceViora, Ltd.20200—
+5K201109CO2 Laser Therapy SystemShanghai Apolo Medical Technology Co., Ltd.20205—
+5K193656SkyPulseFotona D.O.O.202011—
+5K180359BTL-FR2000BTL Industries, Inc.20189—
+5K182270Cellene CO2 Laser SystemBio-Med USA, Inc.20180—
+5K181523Syneron CO2RE SystemSyneron-Candela Corp20180—
+5K180597AcuPulse (previously called AcuPulse 30/40 ST); AcuPulse 40W G; AcuPulse DUOLumenis, Ltd.20183—
+5K173285Joule SystemSciton, Inc20185—
+5K172096FraxisIlooda Co,., Ltd.20172—
+5K163137NIRA Beauty Skin LaserDermal Photonics Corporation20171—
+5K170325Secret RFIlooda Co,., Ltd.201710—
+5K162169EdgeOne CO2 LaserJeisys Medical, Inc.20167—
+5K161925CO2 Laser Therapy MachineBeijing Adss Development Co., Ltd.201614—
+5K161162Frax 1550 for Ellipse Nordlys/ Ellipse Nordlys+, Ellipse Sirius, Ellipse Infinity…Ellipse A/S20164—
+5K160075Accent XLAlma Lasers, Inc.20160—
+5K153124DuraLazeTM HoLEP Laser FiberMedkey, LLC20160—
+5K160012O-pel Laser and families of probe delivery devicesPrecise Light Surgical20160—
+5K153229SuperbiumBios S.R.L.20162—
+5K151306SoleaConvergent Dental, Inc.20151—
+5K150587Cortex Laser SystemCynosure, Inc. Dba Ellman20151—
+5K150161Venus Viva SR DeviceVenus Concept, Ltd.20159—
+5K141868Tria FanpTria Beauty, Inc.20140—
+5K141507Two Skin Treatment SystemSyneron Medical, Ltd.20140—
+5K141658Light ScalpelLightscalpel, LLC20142—
+5K131987Multipulse HoplusAsclepion Laser Technologies GmbH20142—
+5K140009Soprano Ice Multi-Application & Multi-Technology PlatformAlma Lasers, Ltd.201457—
+5K132806Fotona F-22 Laser Handpiece (F-Runner), Fotona FS-01 Laser HandpieceFotona D.D.201470—
+5K132976AdvatxAdvalight Aps20141—
+5K140503Flexiva SF Side-Firing Single-Use Laser FiberBoston Scientific20140—
+5K132975Sphinx JRAllmed Systems, Inc.20141—
+5K140388Lumenis Pulse 120HLumenis, Ltd.201434—
+5K130501IntensifEndymed Medical, Ltd.201457—
+5K131758Surgen UPollogen, Ltd.20135—
+5K131473(Quanta System) Surgical Laser FibersQuanta System Spa201351
+5K130793Newa Skin Therapy SystemEndymion Medical, Ltd.20130—
+5K130420SOLEAConvergent Dental, Inc.201321
+5K130193Fraxel Dual 1550/1927 Laser SystemSolta Medical, Inc.201325—
+5K124003Med-Fibers Surgical Laser Fiber, Med-Fibers Endo-Ent Laser Probes, Med-Fibers End- and…Med-Fibers, Inc.201323—
+5K121977Plasmajet Neutral Plasma Surgery SystemPlasma Surgical Limited20121—
+5K121938Medilas H Rfid Laser FiberDornier Medtech America, Inc.20123—
+5K120926Endobeam Holmium Laser FibersC.R. Bard, Inc.201224—
+5K120513Glow by EndymedEndymed Medical, Ltd.20125—
+5K120433Clear + Brilliant Laser SystemSolta Medical, Inc.20121—
+5K111831MX-7000 MicroxelBio-Med USA, Inc.20111—
+5K111840Emerge Fractional LaserPalomar Medical Products, Inc.20113—
+5K110672Etwo Skin Treatment SystemSyneron, Ltd.20112—
+5K110897Cortex CO2 / ER:Yag Laser SystemSandstone Medical Technologies, LLC20112—
+5K110349Clear+Brilliant Laser SystemSolta Medical, Inc.20116—
+5K101506LUX1540, LUX1440 & LUX2940 Laser HandpiecesPalomar Medical Technologies, Inc.2010156—
+5K100194Optical Integrity Laserguard FibersOptical Integrity, Inc.20100—
+5K100270Artisan Aesthetic SystemPalomar Medical Technologies, Inc.2010157—
+5K100228Versapulse Model P20 Laser SystemLumenis, Inc.20101—
+5K100078Modified Straight Fire Laser FiberBoston Scientific Corp20105—
+5K083616Patholase Family of Pinpointe and Pinpointe Footlaser ND: Yag LasersPatholase, Inc.2009136—
+5K083215Incisive Family of Inpulse ND:Yag LasersIncisive, LLC2009136—
+5K082928Straight Fire Holmium Laser FiberBoston Scientific Corp20086—
+5K073158Sculpture 2.94 ER:Yag SystemHoya Conbio, Inc.20080—
+5K080525Cook Odyssey Holmium Laser System, Model 30WCook Urological, Inc.20080—
+5K073583Modification to Palomar LUX1540 HandpiecePalomar Medical Products, Inc.2008159—
+5K061455Dornier Medilas H 20 LaserDornier Medtech America, Inc.20064—
+5K053457Vapormax IITrimedyne, Inc.20051—
+5K014290Entec Plasma WandsArthrocare Corp.2002119—
+5K014222Arthrocare Controller, Patient Cable, Foot Control, Power CordArthrocare Corp.20022—
+6K260974CO2 Laser Machine (Monica-I,Monica-II)Nanjing Bestview Laser S&T Co., Ltd.20260—
+6K253917ARION ARC SystemPlasma Surgical, Inc.20260—
+6K252561BTL-754FFBTL Industries, Inc.20260—
+6K251836Dermatrix DuoShenzhen Gsd Technology Co., Ltd.20260—
+6K252519CO2 Laser Therapy System (K106)Hebei Keylaser Sci-Tech Co.,Ltd20250—
+6K251031Fiber Laser Treatment Systems (HS-232,HS-233)Shanghai Apolo Medical Technology Co., Ltd.20250—
+6K251632Optimas MAX SystemInMode, Ltd.20251—
+6K250782Fractional CO2 Laser MachineZhengzhou PZ Laser Slim Technology Co., Ltd.20250—
+6K250465CO2 Laser Machine (Lume)Nanjing Bestview Laser S&T Co., Ltd.20250—
+6K251230The Alma Hybrid Laser SystemAlma Lasers, Inc.20250—
+6K250183CO2 Laser System (CO2 Laser SST-L23)Zhuozhou Summer Star Technologies Co., Ltd.20250—
+6K250189AdvaTxAdvalight Aps20250—
+6K241791Medical Diode Laser Systems (GBOX-6H, GBOX-10D , GBOX-12D, GBOX-15D, VELAS Pro-30B15D…Gigaalaser Company, Ltd.20251—
+6K234004Medical diode laser systems (CHARISMA, REGAL)Reveal Lasers, Ltd.20251—
+6K242941CO2 Laser Therapy Systems (SHE-LSP003-1)Beijing Sano Laser S&T Development Co.,Ltd20250—
+6K242183Fractional CO2 Laser Therapy System (EXFU CO2)Weifang Mingliang Electronics Co., Ltd.20240—
+6K233803UltraClear Laser System (N/A)Acclaro Corporation20241—
+6K233157VaporMAX LDD; MOJo LDD; MegaJOULE LDDInnovaquartz, LLC20240—
+6K232133Co2 Laser System, Models: PureLase And VanLaseCpmt Laser (Canadian Pioneer Medical Technology Corporation)20240—
+6K240179Medical Diode Laser (Model: L2)Wuhan Pioon Technology Co., Ltd.20242—
+6K233760Mjolnir Pro. (Multi–electrode plasma)Shenzhen Leaflife Technology Co., Ltd.20240—
+6K233024Alma HarmonyAlma Lasers, Inc.20241—
+6K230077LaserMENeauvia North America20232—
+6K223871Miria Skin Treatment SystemAVAVA, Inc.20232—
+6K230274Medical Diode Laser (M2)Wuhan Pioon Technology Co., Ltd.20232—
+6K221623FlexSys, FlexSys UVB EPL 308 nm, FlexSys UVB EPL lite 308 nm, FlexSys IR 1550 nmGme German Medical Engineering GmbH20230—
+6K222685NIRA Model 2Dermal Photonics Corp20230—
+6K222221Deka HelixEl.En Electronic Engineering Spa20231—
+6K223647CLEAR+BRILLIANT TOUCH® Laser SystemSolta Medical, Inc.20220—