510(k) Report

Devices descending from K003202

759 later devices reach Family of Altus Medical Coolglide Aesthetic Lasers, Models I & II through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+8K162765Venus Velocity Diode Laser SystemVenus Concept, Ltd.20171—
+8K160488Cutera enlighten III Laser SystemCutera, Inc.201613—
+8K161356Matrix LS-40 CO2 Laser SystemShanghai Wonderful Opto-Electrics Tech.Co.,Ltd20160—
+8K160607PicoWay Laser SystemSyneron Candela Corporation201634—
+8K152856Helios IIILaseroptek Co., Ltd.20165—
+8K160480PicoSure WorkstationCynosure, Inc.201620—
+8K160513Quanta System Surgical Laser fibersQuanta System Spa201631
+8K153527PicoWay Laser SystemSyneron Candela Corporation201641—
+8K152529NaturaLase CO2 Laser SystemFocus Medical, LLC20160—
+8K152417Adler MicroMed Laser Surgery FibersAdler Micromed, Inc.20153—
+8K150326PicoWay Laser SystemCandela Corporation201568—
+8K150027CYMAWhitecap Technologies, LLC20150—
+8K143105Picosure WorkstationCynosure, Inc.201549—
+8K142372Pico Way Laser SystemCandela Corpation201470—
+8K140719Picosure WorkstationCynosure, Inc.201450—
+8K133915Galaxy CO2 Laser SystemBeijing Toplaser Technology Co., Ltd.20142—
+8K130793Newa Skin Therapy SystemEndymion Medical, Ltd.20130—
+8K110349Clear+Brilliant Laser SystemSolta Medical, Inc.20116—
+8K100610Lutronic Corporation ECO2 Plus, Denta Iii and Iii+ and SP Iii Laser SystemsLutronic Corporation20113—
+9K261047Dental Diode Laser Device (Laser-Pen)Guilin Kevin Peter Technology Co., Ltd.20260—
+9K2618211565nm Laser Therapy Device (PZ-JG86-01,PZ-JG86-02)Zhengzhou PZ Laser Slim Technology Co., Ltd.20260—
+9K260017Picosecond Nd:YAG Laser Systems (Model: HS-298)Shanghai Apolo Medical Technology Co., Ltd.20260—
+9K260375Nd: YAG Laser Therapy SystemsSanhe Meditech Co., Ltd.20260—
+9K251988Boston iFace (Boston iFace)Boston Aesthetics, Inc.20260—
+9K253123CuRAS hybridClassys, Inc.20250—
+9K252515Q-Switched Nd:Yag laser (K690)Hebei Keylaser Sci-Tech Co.,Ltd20250—
+9K252345Picosecond Laser Device (PF131-BI)Risu Medical Technology Co., Ltd.20250—
+9K252319Q-Switched Nd: YAG Laser machine (LFS-C13U)Sanhe Lefis Electronics Co., Ltd.20250—
+9K252447Picosecond laser device (BMPS4)Hebei Newangie Technology Co., Ltd.20250—
+9K250734OptiLUV DevicePollogen, Ltd.20250—
+9K244060eCO2 3DLutronic Corporation20250—
+9K250782Fractional CO2 Laser MachineZhengzhou PZ Laser Slim Technology Co., Ltd.20250—
+9K240983Discovery Pico; Discovery Pico Plus; Discovery Pico DermQuanta System Spa20251—
+9K250041Medical Picosecond ND: YAG Laser System (PZ-6)Zhengzhou PZ Laser Slim Technology Co., Ltd.20250—
+9K250402AVAVA™ Skin Treatment SystemAVAVA, Inc.20251—
+9K241643WONTECH Surgical Optic Fibers (BA400/BA400R/BA600/BA600R)Wontech Co., Ltd.20252—
+9K241832Unicorn+ RF System (Unicorn+); Unicorn+ RF System (Unicorn+ I); Unicorn+ RF System…Boston Aesthetics, Inc.20251—
+9K243147LGO-Surgical Laser FibersLight Guide Optics International, Ltd.20241—
+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—
+9K242206ActivoDaeju Meditech Engineering Co., Ltd.20240—
+9K242349FoLixLumenis Be, Ltd.20240—
+9K240118Picosecond Nd:YAG Laser SystemSmedtrum Medical Technology Co., Ltd.20240—
+9K222958mJOULE RF System and AccessoriesSciton, Inc20240—
+9K233757TitanPico Laser Workstation (PICO-450)Rhein Laser Technologies Co., Ltd.20240—
+9K240396Elite iQ PRO (M122K1)Cynosure, LLC20240—
+9K232769BeaMed Laser Surgery FibersBt Beamedical Tachnoogies Ltd. (Beamed)20231—
+9K223727LavieenWontech Co., Ltd.20234—
+9K222556BTL-785XBTL Industries, Inc.20235—
+9K230819OmniGuide RFID Surgical Laser FibersOmni-Guide Holdings, Inc.20230—
+9K222685NIRA Model 2Dermal Photonics Corp20230—
+9K221574LUDWIG Electrosurgical DeviceAesthetics Biomedical20220—
+9K213120OW100S (model OW100S-US)Tissue Regeneration Technologies, LLC Dba AS Softwave Trt20220—
+9K222555reepot Nd; YAG laser systemIlooda Co,., Ltd.20220—
+9K220268Picosecond Laser System (Model PS10-A and PS10-B)Beijing Adss Development Co., Ltd.20221—
+9K212663Helios IV 785Laseroptek Co., Ltd.20223—
+9K210084SilkroHironic Co., Ltd.20223—
+9K220793InnoVoyce Laser FiberInnovoyce, LLC20220—
+9K213889PicoStarAsclepion Laser Technologies GmbH20220—
+9K220124YandR System, VoluDerm Handpiece, VoluDerm TipsPollogen, Ltd.20220—
+9K202848S2 Pigment Removal SystemLightsense Technologies, Ltd.20210—
+9K211821DEKA Motus AZEl.En Electronic Engineering Spa20211—
+9K210226PicoSure WorkstationCynosure, LLC20213—
+9K201387Ultrafast, Ultrafast Plus, Ultrafast LiteDentlight, Inc.20210—
+9K201685PotenzaJeisys Medical, Inc.20219—
+9K201735PlaDuo SystemShenB Co., Ltd.20203—
+9K200947InMode System with the Morhpeus8 ApplicatorsInMode, Ltd.202015—
+9K193477Nd: YAG Laser Therapy SystemsBeijing Kes Biology Technology Co., Ltd.20202—
+9K200786Venus EpileveVenus Concept USA, Inc.20200—
+9K192583PicoLazer Laser SystemRohrer Aesthetics, LLC20200—
+9K191842Discovery Pico, Discovery Pico Plus, Discovery Pico DermQuanta System Spa201918—
+9K191685PicoWay Laser SystemCandela Corporation201920—
+9K182355Secret RF Smartcure Applicator with electrodesIlooda Co,., Ltd.20191—
+9K183450EmBody SystemInmode MD, Ltd.20198—
+9K183392PicoLO Nd:YAG Picosecond Laser SystemLaseroptek Co., Ltd.20192—
+9K182997enlighten III Laser SystemCutera, Inc.20180—
+9K181272Picocare FamilyWontech Co., Ltd.20188—
+9K180654PINXEL-RF systemRohrer Aesthetics, LLC20183—
+9K170936Cutera enlighten III Laser SystemCutera, Inc.201710—
+9K161403A.R.C. Laser Surgical Fibers and ProbesA.R.C Laser GmbH20160—
+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—
+10K251981Boston PICO (Boston PICO)Boston Aesthetics, Inc.20260—
+10K254290ZenTite (Unicorn+); ZenTite (Unicorn+I); ZenTite (Unicorn+II); ZenTite (Unicorn+III)Shenzhen Peninsula Medical Group20260—
+10K252369Boston Pico755Boston Aesthetics, Inc.20260—
+10K252745Halo Sterile Single-use Radial Fiber…Micro-Energy Medical Technology Co., Ltd.20251—
+10K253007Laser 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—
+10K252155AVAVA™ Skin Treatment SystemAVAVA, Inc.20250—
+10K251919Thulium Laser System (Deluxlase)Nanjing Bestview Laser S&T Co., Ltd.20250—
+10K243176BLESSING SystemCellah Medical Co., Ltd.20251—
+10K250113neoLaser Laser Surgery FibersG.N.S Neolaser, Ltd.20250—
+10K243957PicoalexWontech Co., Ltd.20250—
+10K242941CO2 Laser Therapy Systems (SHE-LSP003-1)Beijing Sano Laser S&T Development Co.,Ltd20250—
+10K242534HandPICO Fractional Laser Handpiece TipVydence Medical20241—
+10K242688Finiff SystemSkingrab Co., Ltd.20240—
+10K231216PotenzaJeisys Medical, Inc.20244—
+10K231287PotenzaJeisys Medical, Inc.20241—
+10K240991eMVFit (MVF-10M)Weero Co., Ltd.20240—