510(k) Report

Devices descending from K882160

701 later devices reach Coherent System 920 Argon/Dye Photocoagulator through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+8K112013Evolve (R) HPD 980/1470NM Multiwavelength Diode LaserBiolitec, Inc.20126—
+8K110672Etwo Skin Treatment SystemSyneron, Ltd.20112—
+8K110907Palomar Icon (TM) Aesthetic SystemPalomar Medical Technologies, Inc.201157—
+8K103664Primus Aesthetic PlatformPalomar Medical Technologies, Inc.20117—
+8K103288Deka Synchro FTEl.En Electronic Engineering Spa201118—
+8K102755Ceralas E/ 1470NM Fiber-Coupled Diode Laser Family; Crealas HPD Multiwavelenght 980NM/…Biolitec, Inc.201046—
+8K102036Doctor Surgery Diode Lasers FamilyLambda S.P.A.20107—
+8K100726Ceralas D/ 980NM Fiber-Coupled Diode Laser Family, Ceralas E/ 980NM Fiber-Coupled Diode…Biolitec, Inc.201054—
+8K101152Naturalase Diode Laser Family Naturalase Model NL980, Naturalase Diode Laser Family…Focus Medical, LLC20100—
+8K100270Artisan Aesthetic SystemPalomar Medical Technologies, Inc.2010157—
+8K091115ECO2 Laser SystemLutronic Corporation200927—
+8K090639EXELO2, Model 4010Quantel Derma GmbH20090—
+8K091059Foxq 980 LaserA.R.C Laser GmbH20090—
+9K243223Multiple therapy aesthetic treatment device (BHS 202 UNYQUE)Bh Group Us, LLC20260—
+9K261673LED Therapy Device (QLXY-01)Beijing Nubway S&T Co., Ltd.20260—
+9K261817Diode Laser Therapy System (PZ-BDT67-01, PZ-BDT67-02)Zhengzhou PZ Laser Slim Technology Co., Ltd.20260—
+9K254025LED Neck Beauty Mask (ZLD-66A,ZLD-90E,ZLD-130,ZLD-180H)Shenzhen Kaiyan Medical Equipment Co., Ltd.20260—
+9K253309SOGA Lasers therapy system family of Aurora handpiece (Aurora-S); SOGA Lasers therapy…Shenzhen Soga Technology Co., Ltd.20260—
+9K261214Pico Shining (Pico-K; Picofy)Speclipse, Inc.20260—
+9K260153Q-Switched Nd: YAG Laser System (Glamor Q)Nanjing Bestview Laser S&T Co., Ltd.20260—
+9K260017Picosecond Nd:YAG Laser Systems (Model: HS-298)Shanghai Apolo Medical Technology Co., Ltd.20260—
+9K254197Picasso Pro Diode Laser (002-00460)CAO Group, Inc.20260—
+9K253829Medical Ultra-Pico Laser Treatment System (CM-SP-1064&532)Beijing HuaCheng Taike Technology Co., Ltd.20260—
+9K251836Dermatrix DuoShenzhen Gsd Technology Co., Ltd.20260—
+9K252753Vydence Family of LasersVydence Medical Industria E Commercio Ltda20260—
+9K252994LED Therapy Mask (SR11CM, SR11CM1, SR11CM2, SR11CM3, SR11CM4, SR11CM5, SR11CM6, SR11CM7…Guangdong Ace-Tec Co., Ltd.20250—
+9K251464TRI-BEAM PRO, TRI-BEAM (Nd:YAG Laser unit)Jeisys Medical Incorporated20250—
+9K252447Picosecond laser device (BMPS4)Hebei Newangie Technology 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—
+9K251049SurgiLight 1470 Diode Laser System (Model:Halo)Micro-Energy Medical Technology Co., Ltd.20250—
+9K250722Nd: YAG Laser Therapy System (QN-1)Hebei JT Medical Co., Ltd.20250—
+9K250041Medical Picosecond ND: YAG Laser System (PZ-6)Zhengzhou PZ Laser Slim Technology Co., Ltd.20250—
+9K244022308nm UV Phototherapy System (UV-K); 308nm UV Phototherapy System (UV-X); 308nm UV…Boston Aesthetics, Inc.20250—
+9K242593CurrentBody™ LED 4 in 1 Zone Facial Mapping Mask (MK-90C, MK-90M, MK66RB-F, MK-90N)Shenzhen Kaiyan Medical Equipment Co., Ltd.20253—
+9K243492Ulike Reglow Light Therapy Device (UM10)Shenzhen Ulike Smart Electronics Co., Ltd.20253—
+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—
+9K241951Lasya-TrinityBLUECORE COMPANY Co., Ltd.20240—
+9K241293LED Light Therapy Device, ELIXIR MD™Yassen Wellness, LLC20247—
+9K241144Picosecond Nd:YAG Laser (PICOCAREMAJESTY)Wontech Co., Ltd.20241—
+9K233007Picosecond Nd:YAG Laser System; PICO LEGENDAmi, Inc.20241—
+9K233344Regenalase Laser SystemIpg Medical20240—
+9K233473Deka LotusEl.En S.P.A.20241—
+9K240118Picosecond Nd:YAG Laser SystemSmedtrum Medical Technology Co., Ltd.20240—
+9K234104PICOANDY (Q-Switched Nd:YAG Laser)Wontech Co., Ltd.20242—
+9K233760Mjolnir Pro. (Multi–electrode plasma)Shenzhen Leaflife Technology Co., Ltd.20240—
+9K231896Diode Laser Therapy SystemBeijing Adss Development Co., Ltd.20240—
+9K233143PiXel8-RevealRohrer Aesthetics20240—
+9K233224Epilaser ProEpilady 2000, LLC20240—
+9K233077FlashHeal 2 (FlashHeal 2.0)Inwound Aps20240—
+9K233018PICOSECOND Nd:YAG Laser SystemIds, Ltd.20232—
+9K221873NeoGen PSR SystemEnergist Limited20230—
+9K220268Picosecond Laser System (Model PS10-A and PS10-B)Beijing Adss Development Co., Ltd.20221—
+9K212073Alma Diode Tabletop LaserAlma Lasers, Ltd.20220—
+9K211652Renuvion Dermal Handpiece, Renuvion Dermal SystemApyx Medical Corporation (Formerly Bovie Medical Corporation20220—
+9K212573PicoLO PremiumLaseroptek Co., Ltd.20210—
+9K211444CellFX SystemPulse Biosciences, Inc.20213—
+9K202988Tixel SystemNovoxel, Ltd.20211—
+9K200971308nm Excimer SystemXuzhou Kernel Medical Equipment Co., Ltd.20201—
+9K202827308nm Excimer UV-light Skin Therapy SystemShenzhen Gsd Tech Co., Ltd.20200—
+9K193201BTL-785FBtl20208—
+9K201164Venus Viva MD DeviceVenus Concept USA, Inc.20203—
+9K200736Stardust MedI.T.S. Group S.R.L.20200—
+9K192642308nm Excimer SystemChongqing Peninsula Medical Technology Co., Ltd.20202—
+9K191065Venus VivaTMVenus Concept USA, Inc.20200—
+9K191086ExciplexClarteis20194—
+9K191349980nm Diode Laser Therapy DeviceShanghai Apolo Medical Technology Co., Ltd.20190—
+9K190936Q-Switched Nd: YAG Laser SystemShanghai Apolo Medical Technology Co., Ltd.20194—
+9K182616NvisionVLE Imaging System, NvisionVLE Optical Probe, NvisionVLE Inflation SystemNinepoint Medical, Inc.20181—
+9K182669Youlaser CO2Quanta System Spa20181—
+9K181867Deka Smartxide2 TrioEl.En Electronic Engineering Spa20180—
+9K181523Syneron CO2RE SystemSyneron-Candela Corp20180—
+9K180189InMode System with Fractora3D/3D-90 ApplicatorsInmode MD, Ltd.201838—
+9K173692D-Actor 200 Vibration Massage SystemStorz Medical AG20186—
+9K173067LightForce LTS Model 1000, 1500, 2500, and 4000Litecure, LLC20180—
+9K171359Pollogen Legend+ SystemPollogen, Ltd.20174—
+9K171648BM.IrisBluecore Co., Ltd.20172—
+9K171945Discovery Pico, Discovery Pico PlusQuanta System Spa201721—
+9K170637sensiFirmEl Global Trade, Ltd.20173—
+9K162556Lightfusion Led SystemVitage Led, Ltd.20170—
+9K161670Lucid Q-PTP / HWA 55Bison Medical Co, Ltd.20164—
+9K160312Fraxis DuoIlooda Co,., Ltd.201614—
+9K161185LUCERNA Dental LaserViax Dental Lab20160—
+9K161043Profound SystemSyneron Candela Corporation20160—
+9K161199EndyMed Contour HandpieceEndymed Medical, Ltd.20162—
+9K153568InMode Plus SystemInmode MD, Ltd.201618—
+9K152461The Time Machine Series LasersMedical Lasers Manufacturer, Inc.20160—
+9K153717Venus Versa SystemVenus Concept, Ltd.20161—
+9K152529NaturaLase CO2 Laser SystemFocus Medical, LLC20160—
+9K151273InMode FRF ApplicatorInmode MD, Ltd.20163—
+9K150027CYMAWhitecap Technologies, LLC20150—
+9K142376Palomar Icon Aesthetic SystemCynosure, Inc.201413—
+9K140837Lucid LYBio-Med USA, Inc.20140—
+9K133895Deka Smartxide Laser SystemEl.En S.P.A.201410—
+9K131757Tattoostar Effect ComboAsclepion Laser Technologies GmbH20140—
+9K133915Galaxy CO2 Laser SystemBeijing Toplaser Technology Co., Ltd.20142—
+9K131095Deka Synchro Repla: Y Family of Laser SystemsEl.En Electronic Engineering Spa201317—
+9K131839DC 7Dc International, LLC20130—
+9K130028Resurfx 1565NM Laser ModuleLumenis, Ltd.201341—
+9K130465EPIC 10SBiolase Technology, Inc.20130—