510(k) Report

Devices descending from K963094

1,185 later devices reach Cynosure Photogenica LP Dermatological Vascular Lesion Laser through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+11K222555reepot Nd; YAG laser systemIlooda Co,., Ltd.20220—
+11K220268Picosecond Laser System (Model PS10-A and PS10-B)Beijing Adss Development Co., Ltd.20221—
+11K210084SilkroHironic Co., Ltd.20223—
+11K211652Renuvion Dermal Handpiece, Renuvion Dermal SystemApyx Medical Corporation (Formerly Bovie Medical Corporation20220—
+11K220168Skin Care Beauty Mask (Model: MJ-06)Shenzhen Kaiyan Medical CO, Ltd.202234—
+11K220189LISA Laser Surgical FibersOmni-Guide Holdings, Inc.20225—
+11K213889PicoStarAsclepion Laser Technologies GmbH20220—
+11K220124YandR System, VoluDerm Handpiece, VoluDerm TipsPollogen, Ltd.20220—
+11K212127PicocaremajestyWontech Co., Ltd.20226—
+11K201773PicohiHironic Co., Ltd.20215—
+11K210948Omnilux CLEARGlobalmed Technologies202139—
+11K203491PicoLO Nd: YAG Picosecond Laser SystemLaseroptek Co., Ltd.20211—
+11K201171LEONI Laser Fibers: BareFiber Disposable, BareFiber Reusable and Endoprobe DisposableLeoni Fiber Optics, Inc.20210—
+11K201685PotenzaJeisys Medical, Inc.20219—
+11K201735PlaDuo SystemShenB Co., Ltd.20203—
+11K200947InMode System with the Morhpeus8 ApplicatorsInMode, Ltd.202015—
+11K193477Nd: YAG Laser Therapy SystemsBeijing Kes Biology Technology Co., Ltd.20202—
+11K200234Surgical laser fibersQuanta System Spa20202—
+11K191842Discovery Pico, Discovery Pico Plus, Discovery Pico DermQuanta System Spa201918—
+11K191629faceLITEIsmart Marketing Svcs, Ltd.201971—
+11K182355Secret RF Smartcure Applicator with electrodesIlooda Co,., Ltd.20191—
+11K183450EmBody SystemInmode MD, Ltd.20198—
+11K183671LG Pra.L Derma Led MaskLg Electronics.Inc201948—
+11K180654PINXEL-RF systemRohrer Aesthetics, LLC20183—
+11K163197Cook Holmium Laser FiberCook Incorporated20170—
+11K160470SculpSureCynosure, Inc.201620—
+11K160259ZELTIQ CoolSculpting SystemZeltiq Aesthetics, Inc.201615—
+11K160513Quanta System Surgical Laser fibersQuanta System Spa201631
+11K152417Adler MicroMed Laser Surgery FibersAdler Micromed, Inc.20153—
+11K151629Guardian 1000Quanta System Spa20150—
+11K150724SculpSureCynosure, Inc.201521—
+11K150230SculpSureCynosure, Inc.201521—
+11K131059Pioneer Elite Diode LaserCAO Group, Inc.20132—
+11K123443Precise SHP Diode LaserCAO Group, Inc.20139—
+11K121286EPIC 10Biolase Technology, Inc.201231—
+11K111831MX-7000 MicroxelBio-Med USA, Inc.20111—
+11K110243Medart Diode Laser System & AccessoriesMedart A/S20110—
+11K094049Stlase Diode LaserDental Photonics, Inc.201023—
+11K091562Doctor Smile a-810 and B-980 LasersLambda Scientific Spa20098—
+11K082263Ceralas E 980NM Diode Laser, Models E15/980 and E30/980Biolitec, Inc.20081—
+12K261602Eye Recovery Pro (PH-e03)Shenzhen Goodwind Technology Development Co., Ltd.20260—
+12K261601LED Light Therapy Mask (M01, M02, M03, M05, M06, M07, M08)Shenzhen Chuangtong Yigou Technology Co., Ltd.20260—
+12K261407XPREEN LED Light Therapy Masks (XPRE322, XPRE326, XPRE327, XPRE342, XPRE368, XPRE422…Dongguan Miqiang Technology Co., Ltd.20260—
+12K261052LED Light Therapy Masks (LED Face Mask Pro FAC08NA, LED Chest Mask Pro FAC09NA)Guangdong Newdermo Biotech Co., Ltd.20260—
+12K260946LED Light Therapy Mask (K9C-TK, K9C-K, K9P-YK, K9P-K, FM-03BK, FM-09K)Guangdong Newdermo Biotech Co., Ltd.20260—
+12K254079LED Light Therapy Mask (Models: T2, RLD10)Shenzhen Desida Technology Co., Ltd.20260—
+12K253829Medical Ultra-Pico Laser Treatment System (CM-SP-1064&532)Beijing HuaCheng Taike Technology Co., Ltd.20260—
+12K254290ZenTite (Unicorn+); ZenTite (Unicorn+I); ZenTite (Unicorn+II); ZenTite (Unicorn+III)Shenzhen Peninsula Medical Group20260—
+12K252753Vydence Family of LasersVydence Medical Industria E Commercio Ltda20260—
+12K253086LED Light Therapy Device (Models: SG-FM, SG-FE)Sunglor Technology Co., Ltd.20250—
+12K252308LED Beauty Mask (RLBXX)Atop Lighting Co., Ltd.20250—
+12K2527321927nm Thulium Laser System (PZ-DJG75-01, PZ-DJG75-02)Zhengzhou PZ Laser Slim Technology Co., Ltd.20251—
+12K252155AVAVA™ Skin Treatment SystemAVAVA, Inc.20250—
+12K252264MEGELIN LED Light Therapy Mask (JML1, JML1+JML2); MEGELIN LED Light Therapy Mask (JML3…Shenzhen Zhenxing Ruitong Technology Co., Ltd.20252—
+12K252093Light Therapy Mask (1019055)Merchsource, LLC20250—
+12K250581KALA Red Light Face Mask (KALA-01)Shenzhen Kaiyan Medical Equipment Co., Ltd.20250—
+12K243176BLESSING SystemCellah Medical Co., Ltd.20251—
+12K241643WONTECH Surgical Optic Fibers (BA400/BA400R/BA600/BA600R)Wontech Co., Ltd.20252—
+12K242941CO2 Laser Therapy Systems (SHE-LSP003-1)Beijing Sano Laser S&T Development Co.,Ltd20250—
+12K243147LGO-Surgical Laser FibersLight Guide Optics International, Ltd.20241—
+12K242688Finiff SystemSkingrab Co., Ltd.20240—
+12K231216PotenzaJeisys Medical, Inc.20244—
+12K242382décoLITE LED DeviceiSMART Developments, Ltd.20246—
+12K231287PotenzaJeisys Medical, Inc.20241—
+12K240991eMVFit (MVF-10M)Weero Co., Ltd.20240—
+12K241144Picosecond Nd:YAG Laser (PICOCAREMAJESTY)Wontech Co., Ltd.20241—
+12K233123SilkroHironic Co., Ltd.20241—
+12K233007Picosecond Nd:YAG Laser System; PICO LEGENDAmi, Inc.20241—
+12K233120CWM-930S, Fixer DV9Chungwoo Co., Ltd.20240—
+12K233099GladiatorRohrer Aesthetics, LLC20240—
+12K240999Legend X Applicator VOPollogen, Ltd.20241—
+12K233849BTL-499BTL Industries, Inc.20240—
+12K233604BTL-785SBTL Industries, Inc.20243—
+12K234104PICOANDY (Q-Switched Nd:YAG Laser)Wontech Co., Ltd.20242—
+12K230837PlazMagikAgnes Medical Co., Ltd.20240—
+12K233018PICOSECOND Nd:YAG Laser SystemIds, Ltd.20232—
+12K232769BeaMed Laser Surgery FibersBt Beamedical Tachnoogies Ltd. (Beamed)20231—
+12K232532Nd:Yag Laser Therapy SystemsBeijing Unt Technology Co., Ltd.20230—
+12K233147PiXel8-RFRohrer Aesthetics20230—
+12K232223PlaDuo SystemShenB Co., Ltd.20230—
+12K231790The InMode System with the Morpheus8 ApplicatorsInMode, Ltd.202310—
+12K230351LED Facial MaskShenzhen Sungpo Hi-Tech Electronic Co., Ltd.202333—
+12K230819OmniGuide RFID Surgical Laser FibersOmni-Guide Holdings, Inc.20230—
+12K221775LED Light Therapy Mask (model: MK-78, MK-04, MK66-H, MK66R-B, EL00003)Light Tree Ventures Europe B.V.20227—
+12K221946LED Light Therapy Mask (model: MK66R-B)Light Tree Ventures Europe B.V.202218—
+12K221151Beauty LED Mask, Model: KFB265Hunan Guangye Biotechnology Co., Ltd.202241—
+12K212472AgeJetTriworks Group Srl20220—
+12K211000AcutronIlooda Co,., Ltd.20220—
+12K220793InnoVoyce Laser FiberInnovoyce, LLC20220—
+12K211681EONDominion Aesthetic Technologies, Inc.20221—
+12K212573PicoLO PremiumLaseroptek Co., Ltd.20210—
+12K213184MZ Skin LightMAX Supercharged LED Mask 2.0Mz Skin202135—
+12K210877Evolve System with the T3 ApplicatorInMode, Ltd.20215—
+12K201285InMode Evolve System with the Tone ApplicatorInMode, Ltd.20216—
+12K202503ChromeQuanta System Spa202012—
+12K192430Epic 980Biolase, Inc.20195—
+12K181602Pioneer Elite Diode LaserCAO Group, Inc.20190—
+12K181601Precise SHP Diode LaserCAO Group, Inc.20191—
+12K191068Powersculp laser lipolysis systemWuhan Lotuxs Technology Co., Ltd.20196—
+12K190743Venus BlissVenus Concept USA, Inc.20194—