510(k) Report

Devices descending from K022923

656 later devices reach Candela Gentle Yag Laser System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+7K091059Foxq 980 LaserA.R.C Laser GmbH20090—
+8K261817Diode Laser Therapy System (PZ-BDT67-01, PZ-BDT67-02)Zhengzhou PZ Laser Slim Technology Co., Ltd.20260—
+8K261570Picosure WorkstationCynosure, LLC20260—
+8K260017Picosecond Nd:YAG Laser Systems (Model: HS-298)Shanghai Apolo Medical Technology Co., Ltd.20260—
+8K251981Boston PICO (Boston PICO)Boston Aesthetics, Inc.20260—
+8K252369Boston Pico755Boston Aesthetics, Inc.20260—
+8K251988Boston iFace (Boston iFace)Boston Aesthetics, Inc.20260—
+8K251077JOULE 1064nm System and AccessoriesSciton, Inc20250—
+8K252345Picosecond Laser Device (PF131-BI)Risu Medical Technology Co., Ltd.20250—
+8K252155AVAVA™ Skin Treatment SystemAVAVA, Inc.20250—
+8K252447Picosecond laser device (BMPS4)Hebei Newangie Technology Co., Ltd.20250—
+8K251919Thulium Laser System (Deluxlase)Nanjing Bestview Laser S&T Co., Ltd.20250—
+8K252063Medical Diode Laser Systems (BERYLAS-12N); Medical Diode Laser Systems (BERYLAS-15N)…Wuhan Dimed Laser Technology Co., Ltd.20250—
+8K250782Fractional CO2 Laser MachineZhengzhou PZ Laser Slim Technology Co., Ltd.20250—
+8K250041Medical Picosecond ND: YAG Laser System (PZ-6)Zhengzhou PZ Laser Slim Technology Co., Ltd.20250—
+8K243957PicoalexWontech Co., Ltd.20250—
+8K241832Unicorn+ RF System (Unicorn+); Unicorn+ RF System (Unicorn+ I); Unicorn+ RF System…Boston Aesthetics, Inc.20251—
+8K242534HandPICO Fractional Laser Handpiece TipVydence Medical20241—
+8K242183Fractional CO2 Laser Therapy System (EXFU CO2)Weifang Mingliang Electronics Co., Ltd.20240—
+8K241951Lasya-TrinityBLUECORE COMPANY Co., Ltd.20240—
+8K241406LavieenWontech Co., Ltd.20242—
+8K241459MOTUS PRO FamilyEl.En S.P.A.20240—
+8K240386Picosecond Nd:YAG Laser Systems (BL-C10)Shanghai Bele Medical Technology Co.,Ltd20240—
+8K240118Picosecond Nd:YAG Laser SystemSmedtrum Medical Technology Co., Ltd.20240—
+8K222958mJOULE RF System and AccessoriesSciton, Inc20240—
+8K231896Diode Laser Therapy SystemBeijing Adss Development Co., Ltd.20240—
+8K232532Nd:Yag Laser Therapy SystemsBeijing Unt Technology Co., Ltd.20230—
+8K222556BTL-785XBTL Industries, Inc.20235—
+8K230373HELIOS 785 PicoLaseroptek Co., Ltd.20232—
+8K221574LUDWIG Electrosurgical DeviceAesthetics Biomedical20220—
+8K220853PicoWay Laser SystemCandela Corporation20221—
+8K214015Palm NRG cellulite body device (model: Palm NRG body device)Heat IN A Click, LLC20220—
+8K220268Picosecond Laser System (Model PS10-A and PS10-B)Beijing Adss Development Co., Ltd.20221—
+8K212073Alma Diode Tabletop LaserAlma Lasers, Ltd.20220—
+8K210084SilkroHironic Co., Ltd.20223—
+8K213889PicoStarAsclepion Laser Technologies GmbH20220—
+8K220124YandR System, VoluDerm Handpiece, VoluDerm TipsPollogen, Ltd.20220—
+8K212127PicocaremajestyWontech Co., Ltd.20226—
+8K201773PicohiHironic Co., Ltd.20215—
+8K203491PicoLO Nd: YAG Picosecond Laser SystemLaseroptek Co., Ltd.20211—
+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—
+8K200786Venus EpileveVenus Concept USA, Inc.20200—
+8K191855EmFace DeviceInmode MD, Ltd.20191—
+8K191842Discovery Pico, Discovery Pico Plus, Discovery Pico DermQuanta System Spa201918—
+8K182355Secret RF Smartcure Applicator with electrodesIlooda Co,., Ltd.20191—
+8K191349980nm Diode Laser Therapy DeviceShanghai Apolo Medical Technology Co., Ltd.20190—
+8K182616NvisionVLE Imaging System, NvisionVLE Optical Probe, NvisionVLE Inflation SystemNinepoint Medical, Inc.20181—
+8K181095RF-ReliefEl Global Trade, Ltd.20181—
+8K180654PINXEL-RF systemRohrer Aesthetics, LLC20183—
+8K173359Fractional CO2 Surgical Laser SystemAmi, Inc.20180—
+8K173067LightForce LTS Model 1000, 1500, 2500, and 4000Litecure, LLC20180—
+8K172302InMode PLUS SystemInmode MD, Ltd.201713—
+8K162169EdgeOne CO2 LaserJeisys Medical, Inc.20167—
+8K161185LUCERNA Dental LaserViax Dental Lab20160—
+8K161356Matrix LS-40 CO2 Laser SystemShanghai Wonderful Opto-Electrics Tech.Co.,Ltd20160—
+8K152461The Time Machine Series LasersMedical Lasers Manufacturer, Inc.20160—
+8K133891Multipulse TM+1470Asclepion Laser Technologies GmbH20153—
+8K131839DC 7Dc International, LLC20130—
+8K130465EPIC 10SBiolase Technology, Inc.20130—
+8K124003Med-Fibers Surgical Laser Fiber, Med-Fibers Endo-Ent Laser Probes, Med-Fibers End- and…Med-Fibers, Inc.201323—
+8K120810Fiberoptic Laser Delivery SystemFiberoptic Fabrications, Inc.201224—
+8K112442Radial-Emitting Shaped Fiber Optic Delivery SystemBiolitec Medical Devices, Inc.20110—
+9K261738Medical Thulium Fiber Laser Systems (UroFiber 150Q)Rhein Laser Technologies Co., Ltd.20260—
+9K260974CO2 Laser Machine (Monica-I,Monica-II)Nanjing Bestview Laser S&T Co., Ltd.20260—
+9K253829Medical Ultra-Pico Laser Treatment System (CM-SP-1064&532)Beijing HuaCheng Taike Technology Co., Ltd.20260—
+9K254290ZenTite (Unicorn+); ZenTite (Unicorn+I); ZenTite (Unicorn+II); ZenTite (Unicorn+III)Shenzhen Peninsula Medical Group20260—
+9K252753Vydence Family of LasersVydence Medical Industria E Commercio Ltda20260—
+9K251730LIA Console (542-7)Leadoptik, Inc.20250—
+9K253100MultiPulse TFLAsclepion Laser Technologies GmbH20251—
+9K2527321927nm Thulium Laser System (PZ-DJG75-01, PZ-DJG75-02)Zhengzhou PZ Laser Slim Technology Co., Ltd.20251—
+9K250734OptiLUV DevicePollogen, Ltd.20250—
+9K250465CO2 Laser Machine (Lume)Nanjing Bestview Laser S&T Co., Ltd.20250—
+9K243176BLESSING SystemCellah Medical Co., Ltd.20251—
+9K242688Finiff SystemSkingrab Co., Ltd.20240—
+9K231216PotenzaJeisys Medical, Inc.20244—
+9K242598DEFINE System (AG612444A)InMode, Ltd.20240—
+9K231287PotenzaJeisys Medical, Inc.20241—
+9K241144Picosecond Nd:YAG Laser (PICOCAREMAJESTY)Wontech Co., Ltd.20241—
+9K233123SilkroHironic Co., Ltd.20241—
+9K233007Picosecond Nd:YAG Laser System; PICO LEGENDAmi, Inc.20241—
+9K233120CWM-930S, Fixer DV9Chungwoo Co., Ltd.20240—
+9K233099GladiatorRohrer Aesthetics, LLC20240—
+9K240999Legend X Applicator VOPollogen, Ltd.20241—
+9K233849BTL-499BTL Industries, Inc.20240—
+9K232133Co2 Laser System, Models: PureLase And VanLaseCpmt Laser (Canadian Pioneer Medical Technology Corporation)20240—
+9K233604BTL-785SBTL Industries, Inc.20243—
+9K234104PICOANDY (Q-Switched Nd:YAG Laser)Wontech Co., Ltd.20242—
+9K230837PlazMagikAgnes Medical Co., Ltd.20240—
+9K233143PiXel8-RevealRohrer Aesthetics20240—
+9K233018PICOSECOND Nd:YAG Laser SystemIds, Ltd.20232—
+9K233147PiXel8-RFRohrer Aesthetics20230—
+9K232223PlaDuo SystemShenB Co., Ltd.20230—
+9K231790The InMode System with the Morpheus8 ApplicatorsInMode, Ltd.202310—
+9K221597CO2 Laser SystemSmedtrum Medical Technology Co., Ltd.20222—
+9K212472AgeJetTriworks Group Srl20220—
+9K211000AcutronIlooda Co,., Ltd.20220—
+9K212573PicoLO PremiumLaseroptek Co., Ltd.20210—