510(k) Report

Devices descending from K971207

781 later devices reach Softlight Q-Switched (ND:Yag) Laser through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+8K233090DEKA AGAIN PRO familyEl.En S.P.A.20232—
+8K232236EchoQuanta System Spa20230—
+8K231894LED Spectrum therapy instrumentShenzhenshi Sincoheren S&T Development Co., Ltd.20230—
+8K222862SILKPRO Titanium Diode Laser System SILKPRO-S20S-TWCLotuxs Medtech (Suzhou) Co., Ltd.20231—
+8K230293TheraFace MaskTherabody, Inc.202316—
+8K222556BTL-785XBTL Industries, Inc.20235—
+8K230580Diode Laser SystemSmedtrum Medical Technology Co., Ltd.20230—
+8K230816Intense Pulsed Light Treatment SystemShangdong Huamei Technology Co., Ltd.20231—
+8K221623FlexSys, FlexSys UVB EPL 308 nm, FlexSys UVB EPL lite 308 nm, FlexSys IR 1550 nmGme German Medical Engineering GmbH20230—
+8K223544LED light therapy mask (FM-01, FM-02, FM-03)Guangdong Newdermo Biotech Co., Ltd.202339—
+8K230371The Alma Soprano TitaniumAlma Lasers, Inc.20232—
+8K213105Epilaser AbsoluteEpilady 2000, LLC20221—
+8K221268SR-1 Skin Treatment SystemAVAVA, Inc.20223—
+8K221574LUDWIG Electrosurgical DeviceAesthetics Biomedical20220—
+8K213120OW100S (model OW100S-US)Tissue Regeneration Technologies, LLC Dba AS Softwave Trt20220—
+8K222555reepot Nd; YAG laser systemIlooda Co,., Ltd.20220—
+8K220385Intense Pulsed Light EquipmentBeijing Globalipl Development Co., Ltd.20220—
+8K220064Synergy Marble (Model: Opasm)Yrs Group, Inc.20220—
+8K212073Alma Diode Tabletop LaserAlma Lasers, Ltd.20220—
+8K210084SilkroHironic Co., Ltd.20223—
+8K210545Infrared Red blue LED light heat beauty machine, Infrared Red blue LED light heat beauty…Marci Beauty, Inc.20222—
+8K220124YandR System, VoluDerm Handpiece, VoluDerm TipsPollogen, Ltd.20220—
+8K212155TheraFace LEDTheragun, Inc.202142—
+8K202848S2 Pigment Removal SystemLightsense Technologies, Ltd.20210—
+8K212275Dermalux Flex MDAesthetic Technology, Ltd.20214—
+8K212238TheraFace MicrocurrentTheragun, Inc.20210—
+8K202390Aduro Light Beauty MaskShenzhen Kaiyan Medical CO, Ltd.202139—
+8K210226PicoSure WorkstationCynosure, LLC20213—
+8K201685PotenzaJeisys Medical, Inc.20219—
+8K201735PlaDuo SystemShenB Co., Ltd.20203—
+8K201109CO2 Laser Therapy SystemShanghai Apolo Medical Technology Co., Ltd.20205—
+8K200947InMode System with the Morhpeus8 ApplicatorsInMode, Ltd.202015—
+8K193477Nd: YAG Laser Therapy SystemsBeijing Kes Biology Technology Co., Ltd.20202—
+8K200786Venus EpileveVenus Concept USA, Inc.20200—
+8K200116PicoSecond Nd: YAG Laser SystemShanghai Apolo Medical Technology Co., Ltd.20206—
+8K193328IPL + Diode Laser MachineBeijing Globalipl Development Co., Ltd.20200—
+8K192583PicoLazer Laser SystemRohrer Aesthetics, LLC20200—
+8K192430Epic 980Biolase, Inc.20195—
+8K192519Multi-modality workstationBeijing Superlaser Technology Co., Ltd.20192—
+8K191685PicoWay Laser SystemCandela Corporation201920—
+8K181602Pioneer Elite Diode LaserCAO Group, Inc.20190—
+8K181601Precise SHP Diode LaserCAO Group, Inc.20191—
+8K182355Secret RF Smartcure Applicator with electrodesIlooda Co,., Ltd.20191—
+8K191349980nm Diode Laser Therapy DeviceShanghai Apolo Medical Technology Co., Ltd.20190—
+8K191611Diode Laser Therapy SystemsWingderm Electro-Optics, Ltd.201901
+8K183392PicoLO Nd:YAG Picosecond Laser SystemLaseroptek Co., Ltd.20192—
+8K182997enlighten III Laser SystemCutera, Inc.20180—
+8K182616NvisionVLE Imaging System, NvisionVLE Optical Probe, NvisionVLE Inflation SystemNinepoint Medical, Inc.20181—
+8K181486DEKA Motus AYEl.En Electronic Engineering Spa20182—
+8K181272Picocare FamilyWontech Co., Ltd.20188—
+8K172273308nm Excimer SystemChongqing Peninsula Medical Technology Co., Ltd.20185—
+8K180518GME LinScan Lite 808 Laser SystemGme German Medical Engineering GmbH20181—
+8K180654PINXEL-RF systemRohrer Aesthetics, LLC20183—
+8K180967Dental Diode Laser SystemLazon Medical Laser Co., Ltd.20180—
+8K173067LightForce LTS Model 1000, 1500, 2500, and 4000Litecure, LLC20180—
+8K172376Discovery Pico, Discovery Pico PlusQuanta System Spa201720—
+8K171702Exciplex308nmClarteis20175—
+8K171986Sterling Supreme Diode LaserCAO Group, Inc.20171—
+8K170637sensiFirmEl Global Trade, Ltd.20173—
+8K162886Deka Motus AXEl.En Electronic Engineering Spa20171—
+8K170366Laser Peripherals, LLC Family of Bare Laser FibersLaser Peripherals, LLC201713—
+8K170500SIROLaser Advance+Dentsply Sirona201721—
+8K170936Cutera enlighten III Laser SystemCutera, Inc.201710—
+8K162114Photon, Photon PlusZolar Technology & Mfg Co., Inc.20163—
+8K161632FAMILY OF SQUARE EPIL (Alex, Alex2, Nd:Yag, Alex+Nd:Yag)Bios S.R.L.20161—
+8K162169EdgeOne CO2 LaserJeisys Medical, Inc.20167—
+8K161185LUCERNA Dental LaserViax Dental Lab20160—
+8K161043Profound SystemSyneron Candela Corporation20160—
+8K161199EndyMed Contour HandpieceEndymed Medical, Ltd.20162—
+8K153568InMode Plus SystemInmode MD, Ltd.201618—
+8K152461The Time Machine Series LasersMedical Lasers Manufacturer, Inc.20160—
+8K151855SLI Endoprobe, SLI DENT Bare Fiber, SLI HO Bare Fiber, SLI HCS Bare Fiber, SLI Lateral…Surgical Laser Incorporated20160—
+8K151473NaturaLase PiQo4 - NaturaLase Nd:Y AG 1064 Q-switched Laser with 532 nm accessory and…Focus Medical, LLC201537—
+8K150587Cortex Laser SystemCynosure, Inc. Dba Ellman20151—
+8K133891Multipulse TM+1470Asclepion Laser Technologies GmbH20153—
+8K140470Oberon: Laser Surgery Fiber, Atraumatic Surgery Fiber, Side Fire Fiber, Radial Emission…Oberon GmbH Fiber Technologies20145—
+8K142226Pilot Ultra Diode LaserCAO Group, Inc.20140—
+8K142225Pilot Elite Diode LaserCAO Group, Inc.20140—
+8K131839DC 7Dc International, LLC20130—
+8K131473(Quanta System) Surgical Laser FibersQuanta System Spa201351
+8K130465EPIC 10SBiolase Technology, Inc.20130—
+8K111689StlaseDental Photonics, Inc.201222—
+9K260945Ultima System (UL-800);Ultimate Face Package (UL-800-Face-Set);Ultimate Shape Extension…Fit-Pro KFT (Ltd.) - DBA E-Fit20260—
+9K261047Dental Diode Laser Device (Laser-Pen)Guilin Kevin Peter Technology Co., Ltd.20260—
+9K261817Diode Laser Therapy System (PZ-BDT67-01, PZ-BDT67-02)Zhengzhou PZ Laser Slim Technology Co., Ltd.20260—
+9K260767Facial Beauty Device (Facial Mask LED Beauty Device A-901; Facial LED & EMS Beauty…Kam Yuen Plastic Products, Ltd.20260—
+9K261738Medical Thulium Fiber Laser Systems (UroFiber 150Q)Rhein Laser Technologies Co., Ltd.20260—
+9K261570Picosure WorkstationCynosure, LLC20260—
+9K260715CurrentBody Skin LED Multi Light Therapy Mask (MK-110D)The Beauty Tech Group, Ltd.20260—
+9K260895Ulike Clear Zero (YC10 BU)Guangxi Ulike Medical Technology Co., Ltd.20260—
+9K260974CO2 Laser Machine (Monica-I,Monica-II)Nanjing Bestview Laser S&T Co., Ltd.20260—
+9K260017Picosecond Nd:YAG Laser Systems (Model: HS-298)Shanghai Apolo Medical Technology Co., Ltd.20260—
+9K260511Ulike Reglow Light Therapy Device (UM10)Shenzhen Ulike Smart Electronics Co., Ltd.20260—
+9K254197Picasso Pro Diode Laser (002-00460)CAO Group, Inc.20260—
+9K253874LED Therapy Light (COB1400, HP1800PRO)Shenzhen Hanhua Opto Co., Ltd.20260—
+9K251981Boston PICO (Boston PICO)Boston Aesthetics, Inc.20260—
+9K254290ZenTite (Unicorn+); ZenTite (Unicorn+I); ZenTite (Unicorn+II); ZenTite (Unicorn+III)Shenzhen Peninsula Medical Group20260—
+9K252603HIGHERDOSE Body Sculptor (Model: GS-03)Shenzhen Kaiyan Medical Equipment Co., Ltd.20260—
+9K252369Boston Pico755Boston Aesthetics, Inc.20260—
+9K253400LED Light Therapy Face Mask (FM60X, FM60X-B, FM60X-W, FM80-W, FM80, VAP1, FM100X…Shenzhen Saidi Light Therapy Technology Co., Ltd.20250—