510(k) Report

Devices descending from K014040

739 later devices reach Family of Altus Medical Modified Coolglide Aesthetic Lasers, Models Coolglide… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+8K192695InMode System with the Morpheus8 (Fractora) ApplicatorsInmode MD, Ltd.201916—
+8K191855EmFace DeviceInmode MD, Ltd.20191—
+8K191685PicoWay Laser SystemCandela Corporation201920—
+8K183392PicoLO Nd:YAG Picosecond Laser SystemLaseroptek Co., Ltd.20192—
+8K182997enlighten III Laser SystemCutera, Inc.20180—
+8K181272Picocare FamilyWontech Co., Ltd.20188—
+8K181095RF-ReliefEl Global Trade, Ltd.20181—
+8K173503Pollogen Legend SystemPollogen, Ltd.20183—
+8K172302InMode PLUS SystemInmode MD, Ltd.201713—
+8K172376Discovery Pico, Discovery Pico PlusQuanta System Spa201720—
+8K172096FraxisIlooda Co,., Ltd.20172—
+8K170325Secret RFIlooda Co,., Ltd.201710—
+8K170366Laser Peripherals, LLC Family of Bare Laser FibersLaser Peripherals, LLC201713—
+8K170936Cutera enlighten III Laser SystemCutera, Inc.201710—
+8K162765Venus Velocity Diode Laser SystemVenus Concept, Ltd.20171—
+8K161356Matrix LS-40 CO2 Laser SystemShanghai Wonderful Opto-Electrics Tech.Co.,Ltd20160—
+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—
+8K140470Oberon: Laser Surgery Fiber, Atraumatic Surgery Fiber, Side Fire Fiber, Radial Emission…Oberon GmbH Fiber Technologies20145—
+8K131473(Quanta System) Surgical Laser FibersQuanta System Spa201351
+8K111831MX-7000 MicroxelBio-Med USA, Inc.20111—
+9K261570Picosure WorkstationCynosure, LLC20260—
+9K260017Picosecond Nd:YAG Laser Systems (Model: HS-298)Shanghai Apolo Medical Technology Co., Ltd.20260—
+9K251981Boston PICO (Boston PICO)Boston Aesthetics, Inc.20260—
+9K252369Boston Pico755Boston Aesthetics, Inc.20260—
+9K251988Boston iFace (Boston iFace)Boston Aesthetics, Inc.20260—
+9K252345Picosecond Laser Device (PF131-BI)Risu Medical Technology Co., Ltd.20250—
+9K252155AVAVA™ Skin Treatment SystemAVAVA, Inc.20250—
+9K250776Lithoblast Single Use Holmium Laser FibersDawell Medical, LLC20250—
+9K252447Picosecond laser device (BMPS4)Hebei Newangie Technology Co., Ltd.20250—
+9K251919Thulium Laser System (Deluxlase)Nanjing Bestview Laser S&T Co., Ltd.20250—
+9K250734OptiLUV DevicePollogen, Ltd.20250—
+9K250782Fractional CO2 Laser MachineZhengzhou PZ Laser Slim Technology Co., Ltd.20250—
+9K250041Medical Picosecond ND: YAG Laser System (PZ-6)Zhengzhou PZ Laser Slim Technology Co., Ltd.20250—
+9K243957PicoalexWontech Co., Ltd.20250—
+9K241832Unicorn+ RF System (Unicorn+); Unicorn+ RF System (Unicorn+ I); Unicorn+ RF System…Boston Aesthetics, Inc.20251—
+9K242534HandPICO Fractional Laser Handpiece TipVydence Medical20241—
+9K241670Fractional CO2 Laser Therapy System (FG900-S); Fractional CO2 Laser Therapy System…Beijing Adss Development Co., Ltd.20241—
+9K242598DEFINE System (AG612444A)InMode, Ltd.20240—
+9K242183Fractional CO2 Laser Therapy System (EXFU CO2)Weifang Mingliang Electronics Co., Ltd.20240—
+9K241406LavieenWontech Co., Ltd.20242—
+9K241459MOTUS PRO FamilyEl.En S.P.A.20240—
+9K240386Picosecond Nd:YAG Laser Systems (BL-C10)Shanghai Bele Medical Technology Co.,Ltd20240—
+9K233157VaporMAX LDD; MOJo LDD; MegaJOULE LDDInnovaquartz, LLC20240—
+9K240118Picosecond Nd:YAG Laser SystemSmedtrum Medical Technology Co., Ltd.20240—
+9K222958mJOULE RF System and AccessoriesSciton, Inc20240—
+9K232106Air Gap FiberWontech Co., Ltd.20240—
+9K232532Nd:Yag Laser Therapy SystemsBeijing Unt Technology Co., Ltd.20230—
+9K222556BTL-785XBTL Industries, Inc.20235—
+9K230373HELIOS 785 PicoLaseroptek Co., Ltd.20232—
+9K221574LUDWIG Electrosurgical DeviceAesthetics Biomedical20220—
+9K220853PicoWay Laser SystemCandela Corporation20221—
+9K220268Picosecond Laser System (Model PS10-A and PS10-B)Beijing Adss Development Co., Ltd.20221—
+9K210084SilkroHironic Co., Ltd.20223—
+9K220189LISA Laser Surgical FibersOmni-Guide Holdings, Inc.20225—
+9K213889PicoStarAsclepion Laser Technologies GmbH20220—
+9K220124YandR System, VoluDerm Handpiece, VoluDerm TipsPollogen, Ltd.20220—
+9K212127PicocaremajestyWontech Co., Ltd.20226—
+9K201773PicohiHironic Co., Ltd.20215—
+9K203491PicoLO Nd: YAG Picosecond Laser SystemLaseroptek Co., Ltd.20211—
+9K201171LEONI Laser Fibers: BareFiber Disposable, BareFiber Reusable and Endoprobe DisposableLeoni Fiber Optics, Inc.20210—
+9K201685PotenzaJeisys Medical, Inc.20219—
+9K201735PlaDuo SystemShenB Co., Ltd.20203—
+9K200947InMode System with the Morhpeus8 ApplicatorsInMode, Ltd.202015—
+9K200786Venus EpileveVenus Concept USA, Inc.20200—
+9K200234Surgical laser fibersQuanta System Spa20202—
+9K191842Discovery Pico, Discovery Pico Plus, Discovery Pico DermQuanta System Spa201918—
+9K182355Secret RF Smartcure Applicator with electrodesIlooda Co,., Ltd.20191—
+9K183450EmBody SystemInmode MD, Ltd.20198—
+9K180654PINXEL-RF systemRohrer Aesthetics, LLC20183—
+9K173359Fractional CO2 Surgical Laser SystemAmi, Inc.20180—
+9K163197Cook Holmium Laser FiberCook Incorporated20170—
+9K160513Quanta System Surgical Laser fibersQuanta System Spa201631
+9K152417Adler MicroMed Laser Surgery FibersAdler Micromed, Inc.20153—
+10K253829Medical Ultra-Pico Laser Treatment System (CM-SP-1064&532)Beijing HuaCheng Taike Technology Co., Ltd.20260—
+10K254290ZenTite (Unicorn+); ZenTite (Unicorn+I); ZenTite (Unicorn+II); ZenTite (Unicorn+III)Shenzhen Peninsula Medical Group20260—
+10K252753Vydence Family of LasersVydence Medical Industria E Commercio Ltda20260—
+10K2527321927nm Thulium Laser System (PZ-DJG75-01, PZ-DJG75-02)Zhengzhou PZ Laser Slim Technology Co., Ltd.20251—
+10K243176BLESSING SystemCellah Medical Co., Ltd.20251—
+10K241643WONTECH Surgical Optic Fibers (BA400/BA400R/BA600/BA600R)Wontech Co., Ltd.20252—
+10K242941CO2 Laser Therapy Systems (SHE-LSP003-1)Beijing Sano Laser S&T Development Co.,Ltd20250—
+10K243147LGO-Surgical Laser FibersLight Guide Optics International, Ltd.20241—
+10K242688Finiff SystemSkingrab Co., Ltd.20240—
+10K231216PotenzaJeisys Medical, Inc.20244—
+10K231287PotenzaJeisys Medical, Inc.20241—
+10K240991eMVFit (MVF-10M)Weero Co., Ltd.20240—
+10K241144Picosecond Nd:YAG Laser (PICOCAREMAJESTY)Wontech Co., Ltd.20241—
+10K233123SilkroHironic Co., Ltd.20241—
+10K233007Picosecond Nd:YAG Laser System; PICO LEGENDAmi, Inc.20241—
+10K233120CWM-930S, Fixer DV9Chungwoo Co., Ltd.20240—
+10K233099GladiatorRohrer Aesthetics, LLC20240—
+10K240999Legend X Applicator VOPollogen, Ltd.20241—
+10K233849BTL-499BTL Industries, Inc.20240—
+10K233604BTL-785SBTL Industries, Inc.20243—
+10K234104PICOANDY (Q-Switched Nd:YAG Laser)Wontech Co., Ltd.20242—
+10K230837PlazMagikAgnes Medical Co., Ltd.20240—
+10K233018PICOSECOND Nd:YAG Laser SystemIds, Ltd.20232—
+10K232769BeaMed Laser Surgery FibersBt Beamedical Tachnoogies Ltd. (Beamed)20231—
+10K233147PiXel8-RFRohrer Aesthetics20230—
+10K232223PlaDuo SystemShenB Co., Ltd.20230—