510(k) Report

Devices descending from K990718

745 later devices reach Orion Series Surgical Laser System (SL Seriesq-Switched ND:Yag Configuration) through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+9K214015Palm NRG cellulite body device (model: Palm NRG body device)Heat IN A Click, LLC20220—
+9K222555reepot Nd; YAG laser systemIlooda Co,., Ltd.20220—
+9K213674CellFX SystemPulse Biosciences, Inc.20220—
+9K222075CellFX SystemPulse Biosciences, Inc.20220—
+9K221671CellFX® SystemPulse Biosciences, Inc.20220—
+9K212663Helios IV 785Laseroptek Co., Ltd.20223—
+9K220189LISA Laser Surgical FibersOmni-Guide Holdings, Inc.20225—
+9K211639BTL-785WBTL Industries, Inc.20227—
+9K202848S2 Pigment Removal SystemLightsense Technologies, Ltd.20210—
+9K212107ReversoIntelis Instruments, Ltd.20211—
+9K211821DEKA Motus AZEl.En Electronic Engineering Spa20211—
+9K201171LEONI Laser Fibers: BareFiber Disposable, BareFiber Reusable and Endoprobe DisposableLeoni Fiber Optics, Inc.20210—
+9K210226PicoSure WorkstationCynosure, LLC20213—
+9K193477Nd: YAG Laser Therapy SystemsBeijing Kes Biology Technology Co., Ltd.20202—
+9K200116PicoSecond Nd: YAG Laser SystemShanghai Apolo Medical Technology Co., Ltd.20206—
+9K200234Surgical laser fibersQuanta System Spa20202—
+9K192545PotenzaJeisys Medical Incorporated202020—
+9K192583PicoLazer Laser SystemRohrer Aesthetics, LLC20200—
+9K192695InMode System with the Morpheus8 (Fractora) ApplicatorsInmode MD, Ltd.201916—
+9K191855EmFace DeviceInmode MD, Ltd.20191—
+9K191685PicoWay Laser SystemCandela Corporation201920—
+9K183392PicoLO Nd:YAG Picosecond Laser SystemLaseroptek Co., Ltd.20192—
+9K182997enlighten III Laser SystemCutera, Inc.20180—
+9K181272Picocare FamilyWontech Co., Ltd.20188—
+9K181095RF-ReliefEl Global Trade, Ltd.20181—
+9K173503Pollogen Legend SystemPollogen, Ltd.20183—
+9K172302InMode PLUS SystemInmode MD, Ltd.201713—
+9K172376Discovery Pico, Discovery Pico PlusQuanta System Spa201720—
+9K172096FraxisIlooda Co,., Ltd.20172—
+9K170325Secret RFIlooda Co,., Ltd.201710—
+9K163197Cook Holmium Laser FiberCook Incorporated20170—
+9K170936Cutera enlighten III Laser SystemCutera, Inc.201710—
+9K162765Venus Velocity Diode Laser SystemVenus Concept, Ltd.20171—
+9K160513Quanta System Surgical Laser fibersQuanta System Spa201631
+9K152417Adler MicroMed Laser Surgery FibersAdler Micromed, Inc.20153—
+9K151473NaturaLase PiQo4 - NaturaLase Nd:Y AG 1064 Q-switched Laser with 532 nm accessory and…Focus Medical, LLC201537—
+9K111831MX-7000 MicroxelBio-Med USA, Inc.20111—
+10K261570Picosure WorkstationCynosure, LLC20260—
+10K260017Picosecond Nd:YAG Laser Systems (Model: HS-298)Shanghai Apolo Medical Technology Co., Ltd.20260—
+10K251981Boston PICO (Boston PICO)Boston Aesthetics, Inc.20260—
+10K252369Boston Pico755Boston Aesthetics, Inc.20260—
+10K251988Boston iFace (Boston iFace)Boston Aesthetics, Inc.20260—
+10K252345Picosecond Laser Device (PF131-BI)Risu Medical Technology Co., Ltd.20250—
+10K252155AVAVA™ Skin Treatment SystemAVAVA, Inc.20250—
+10K252447Picosecond laser device (BMPS4)Hebei Newangie Technology Co., Ltd.20250—
+10K251919Thulium Laser System (Deluxlase)Nanjing Bestview Laser S&T Co., Ltd.20250—
+10K250734OptiLUV DevicePollogen, Ltd.20250—
+10K250782Fractional CO2 Laser MachineZhengzhou PZ Laser Slim Technology Co., Ltd.20250—
+10K250041Medical Picosecond ND: YAG Laser System (PZ-6)Zhengzhou PZ Laser Slim Technology Co., Ltd.20250—
+10K243957PicoalexWontech Co., Ltd.20250—
+10K241643WONTECH Surgical Optic Fibers (BA400/BA400R/BA600/BA600R)Wontech Co., Ltd.20252—
+10K241832Unicorn+ RF System (Unicorn+); Unicorn+ RF System (Unicorn+ I); Unicorn+ RF System…Boston Aesthetics, Inc.20251—
+10K242941CO2 Laser Therapy Systems (SHE-LSP003-1)Beijing Sano Laser S&T Development Co.,Ltd20250—
+10K243147LGO-Surgical Laser FibersLight Guide Optics International, Ltd.20241—
+10K242534HandPICO Fractional Laser Handpiece TipVydence Medical20241—
+10K242598DEFINE System (AG612444A)InMode, Ltd.20240—
+10K242183Fractional CO2 Laser Therapy System (EXFU CO2)Weifang Mingliang Electronics Co., Ltd.20240—
+10K241406LavieenWontech Co., Ltd.20242—
+10K241459MOTUS PRO FamilyEl.En S.P.A.20240—
+10K240386Picosecond Nd:YAG Laser Systems (BL-C10)Shanghai Bele Medical Technology Co.,Ltd20240—
+10K240118Picosecond Nd:YAG Laser SystemSmedtrum Medical Technology Co., Ltd.20240—
+10K222958mJOULE RF System and AccessoriesSciton, Inc20240—
+10K232769BeaMed Laser Surgery FibersBt Beamedical Tachnoogies Ltd. (Beamed)20231—
+10K232532Nd:Yag Laser Therapy SystemsBeijing Unt Technology Co., Ltd.20230—
+10K222556BTL-785XBTL Industries, Inc.20235—
+10K230373HELIOS 785 PicoLaseroptek Co., Ltd.20232—
+10K230819OmniGuide RFID Surgical Laser FibersOmni-Guide Holdings, Inc.20230—
+10K221574LUDWIG Electrosurgical DeviceAesthetics Biomedical20220—
+10K220853PicoWay Laser SystemCandela Corporation20221—
+10K220268Picosecond Laser System (Model PS10-A and PS10-B)Beijing Adss Development Co., Ltd.20221—
+10K210084SilkroHironic Co., Ltd.20223—
+10K220793InnoVoyce Laser FiberInnovoyce, LLC20220—
+10K213889PicoStarAsclepion Laser Technologies GmbH20220—
+10K220124YandR System, VoluDerm Handpiece, VoluDerm TipsPollogen, Ltd.20220—
+10K212127PicocaremajestyWontech Co., Ltd.20226—
+10K201773PicohiHironic Co., Ltd.20215—
+10K203491PicoLO Nd: YAG Picosecond Laser SystemLaseroptek Co., Ltd.20211—
+10K201685PotenzaJeisys Medical, Inc.20219—
+10K201735PlaDuo SystemShenB Co., Ltd.20203—
+10K200947InMode System with the Morhpeus8 ApplicatorsInMode, Ltd.202015—
+10K200786Venus EpileveVenus Concept USA, Inc.20200—
+10K191842Discovery Pico, Discovery Pico Plus, Discovery Pico DermQuanta System Spa201918—
+10K182355Secret RF Smartcure Applicator with electrodesIlooda Co,., Ltd.20191—
+10K183450EmBody SystemInmode MD, Ltd.20198—
+10K180654PINXEL-RF systemRohrer Aesthetics, LLC20183—
+10K173359Fractional CO2 Surgical Laser SystemAmi, Inc.20180—
+10K161403A.R.C. Laser Surgical Fibers and ProbesA.R.C Laser GmbH20160—
+11K253829Medical Ultra-Pico Laser Treatment System (CM-SP-1064&532)Beijing HuaCheng Taike Technology Co., Ltd.20260—
+11K254290ZenTite (Unicorn+); ZenTite (Unicorn+I); ZenTite (Unicorn+II); ZenTite (Unicorn+III)Shenzhen Peninsula Medical Group20260—
+11K252753Vydence Family of LasersVydence Medical Industria E Commercio Ltda20260—
+11K252745Halo Sterile Single-use Radial Fiber…Micro-Energy Medical Technology Co., Ltd.20251—
+11K253007Laser Fiber (PT-OF-A-S); Laser Fiber (PT-OF-B-S); Laser Fiber (PT-OF-C-S); Laser Fiber…Guangzhou Potent Medical Equipment Joint-Stock Co., Ltd.20250—
+11K2527321927nm Thulium Laser System (PZ-DJG75-01, PZ-DJG75-02)Zhengzhou PZ Laser Slim Technology Co., Ltd.20251—
+11K243176BLESSING SystemCellah Medical Co., Ltd.20251—
+11K250113neoLaser Laser Surgery FibersG.N.S Neolaser, Ltd.20250—
+11K242688Finiff SystemSkingrab Co., Ltd.20240—
+11K231216PotenzaJeisys Medical, Inc.20244—
+11K231287PotenzaJeisys Medical, Inc.20241—
+11K240991eMVFit (MVF-10M)Weero Co., Ltd.20240—
+11K241144Picosecond Nd:YAG Laser (PICOCAREMAJESTY)Wontech Co., Ltd.20241—