510(k) Report

Devices descending from K941841

1,178 later devices reach Smartscan through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+9K201735PlaDuo SystemShenB Co., Ltd.20203—
+9K202041Opera EvoQuanta System Spa20200—
+9K200947InMode System with the Morhpeus8 ApplicatorsInMode, Ltd.202015—
+9K193477Nd: YAG Laser Therapy SystemsBeijing Kes Biology Technology Co., Ltd.20202—
+9K200116PicoSecond Nd: YAG Laser SystemShanghai Apolo Medical Technology Co., Ltd.20206—
+9K191855EmFace DeviceInmode MD, Ltd.20191—
+9K191629faceLITEIsmart Marketing Svcs, Ltd.201971—
+9K182355Secret RF Smartcure Applicator with electrodesIlooda Co,., Ltd.20191—
+9K183671LG Pra.L Derma Led MaskLg Electronics.Inc201948—
+9K181095RF-ReliefEl Global Trade, Ltd.20181—
+9K180654PINXEL-RF systemRohrer Aesthetics, LLC20183—
+9K172302InMode PLUS SystemInmode MD, Ltd.201713—
+9K172376Discovery Pico, Discovery Pico PlusQuanta System Spa201720—
+9K161356Matrix LS-40 CO2 Laser SystemShanghai Wonderful Opto-Electrics Tech.Co.,Ltd20160—
+9K151629Guardian 1000Quanta System Spa20150—
+9K131059Pioneer Elite Diode LaserCAO Group, Inc.20132—
+9K123443Precise SHP Diode LaserCAO Group, Inc.20139—
+9K121286EPIC 10Biolase Technology, Inc.201231—
+9K120023Zeltiq CoolsculptingZeltiq Aesthetics, Inc.201231—
+9K111831MX-7000 MicroxelBio-Med USA, Inc.20111—
+9K110243Medart Diode Laser System & AccessoriesMedart A/S20110—
+9K094049Stlase Diode LaserDental Photonics, Inc.201023—
+9K091562Doctor Smile a-810 and B-980 LasersLambda Scientific Spa20098—
+9K082263Ceralas E 980NM Diode Laser, Models E15/980 and E30/980Biolitec, Inc.20081—
+10K261602Eye Recovery Pro (PH-e03)Shenzhen Goodwind Technology Development Co., Ltd.20260—
+10K261601LED Light Therapy Mask (M01, M02, M03, M05, M06, M07, M08)Shenzhen Chuangtong Yigou Technology Co., Ltd.20260—
+10K261407XPREEN LED Light Therapy Masks (XPRE322, XPRE326, XPRE327, XPRE342, XPRE368, XPRE422…Dongguan Miqiang Technology Co., Ltd.20260—
+10K261052LED Light Therapy Masks (LED Face Mask Pro FAC08NA, LED Chest Mask Pro FAC09NA)Guangdong Newdermo Biotech Co., Ltd.20260—
+10K260946LED Light Therapy Mask (K9C-TK, K9C-K, K9P-YK, K9P-K, FM-03BK, FM-09K)Guangdong Newdermo Biotech Co., Ltd.20260—
+10K260017Picosecond Nd:YAG Laser Systems (Model: HS-298)Shanghai Apolo Medical Technology Co., Ltd.20260—
+10K254079LED Light Therapy Mask (Models: T2, RLD10)Shenzhen Desida Technology Co., Ltd.20260—
+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—
+10K253086LED Light Therapy Device (Models: SG-FM, SG-FE)Sunglor Technology Co., Ltd.20250—
+10K252308LED Beauty Mask (RLBXX)Atop Lighting Co., Ltd.20250—
+10K2527321927nm Thulium Laser System (PZ-DJG75-01, PZ-DJG75-02)Zhengzhou PZ Laser Slim Technology Co., Ltd.20251—
+10K252155AVAVA™ Skin Treatment SystemAVAVA, Inc.20250—
+10K252264MEGELIN LED Light Therapy Mask (JML1, JML1+JML2); MEGELIN LED Light Therapy Mask (JML3…Shenzhen Zhenxing Ruitong Technology Co., Ltd.20252—
+10K252093Light Therapy Mask (1019055)Merchsource, LLC20250—
+10K252447Picosecond laser device (BMPS4)Hebei Newangie Technology Co., Ltd.20250—
+10K250734OptiLUV DevicePollogen, Ltd.20250—
+10K250581KALA Red Light Face Mask (KALA-01)Shenzhen Kaiyan Medical Equipment Co., Ltd.20250—
+10K243176BLESSING SystemCellah Medical Co., Ltd.20251—
+10K250041Medical Picosecond ND: YAG Laser System (PZ-6)Zhengzhou PZ Laser Slim Technology Co., Ltd.20250—
+10K242688Finiff SystemSkingrab Co., Ltd.20240—
+10K241670Fractional CO2 Laser Therapy System (FG900-S); Fractional CO2 Laser Therapy System…Beijing Adss Development Co., Ltd.20241—
+10K231216PotenzaJeisys Medical, Inc.20244—
+10K242598DEFINE System (AG612444A)InMode, Ltd.20240—
+10K242382décoLITE LED DeviceiSMART Developments, Ltd.20246—
+10K231287PotenzaJeisys Medical, Inc.20241—
+10K241144Picosecond Nd:YAG Laser (PICOCAREMAJESTY)Wontech Co., Ltd.20241—
+10K233123SilkroHironic Co., Ltd.20241—
+10K241459MOTUS PRO FamilyEl.En S.P.A.20240—
+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—
+10K240118Picosecond Nd:YAG Laser SystemSmedtrum Medical Technology Co., Ltd.20240—
+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—
+10K232532Nd:Yag Laser Therapy SystemsBeijing Unt Technology Co., Ltd.20230—
+10K233147PiXel8-RFRohrer Aesthetics20230—
+10K232223PlaDuo SystemShenB Co., Ltd.20230—
+10K231790The InMode System with the Morpheus8 ApplicatorsInMode, Ltd.202310—
+10K230351LED Facial MaskShenzhen Sungpo Hi-Tech Electronic Co., Ltd.202333—
+10K221775LED Light Therapy Mask (model: MK-78, MK-04, MK66-H, MK66R-B, EL00003)Light Tree Ventures Europe B.V.20227—
+10K221946LED Light Therapy Mask (model: MK66R-B)Light Tree Ventures Europe B.V.202218—
+10K220268Picosecond Laser System (Model PS10-A and PS10-B)Beijing Adss Development Co., Ltd.20221—
+10K221151Beauty LED Mask, Model: KFB265Hunan Guangye Biotechnology Co., Ltd.202241—
+10K212472AgeJetTriworks Group Srl20220—
+10K211000AcutronIlooda Co,., Ltd.20220—
+10K213889PicoStarAsclepion Laser Technologies GmbH20220—
+10K212573PicoLO PremiumLaseroptek Co., Ltd.20210—
+10K213184MZ Skin LightMAX Supercharged LED Mask 2.0Mz Skin202135—
+10K192430Epic 980Biolase, Inc.20195—
+10K191842Discovery Pico, Discovery Pico Plus, Discovery Pico DermQuanta System Spa201918—
+10K181602Pioneer Elite Diode LaserCAO Group, Inc.20190—
+10K181601Precise SHP Diode LaserCAO Group, Inc.20191—
+10K183450EmBody SystemInmode MD, Ltd.20198—
+10K180967Dental Diode Laser SystemLazon Medical Laser Co., Ltd.20180—
+10K173359Fractional CO2 Surgical Laser SystemAmi, Inc.20180—
+10K171986Sterling Supreme Diode LaserCAO Group, Inc.20171—
+10K170500SIROLaser Advance+Dentsply Sirona201721—
+10K162114Photon, Photon PlusZolar Technology & Mfg Co., Inc.20163—
+10K151179ZELTIQ CoolSculpting SystemZeltiq Aesthetics, Inc.201526—
+10K142491ZEL TIQ CoolSculpting SystemZeltiq Aesthetics, Inc.201527—
+10K142226Pilot Ultra Diode LaserCAO Group, Inc.20140—
+10K142225Pilot Elite Diode LaserCAO Group, Inc.20140—
+10K133212Zeltiq Coolsculpting SystemZeltiq Aesthetics, Inc.201430—
+10K111689StlaseDental Photonics, Inc.201222—
+11K261047Dental Diode Laser Device (Laser-Pen)Guilin Kevin Peter Technology Co., Ltd.20260—
+11K254185Potenza PrimeJeisys Medical Incorporated20260—
+11K2615891927nm Thulium Laser System (PZ-DJG85-01, PZ-DJG85-02)Zhengzhou PZ Laser Slim Technology Co., Ltd.20260—
+11K253859Scarlet Pro (Scarlet Pro)VIOL Co., Ltd.20260—
+11K261851LED Light Therapy Mask (JML1, JML1+JML2); LED Light Therapy Mask (JML3, JML3+JML4); LED…Shenzhen Qianyu Technology Co., Ltd.20260—
+11K253484Lutronic GeniusCynosure Lutronic Technology Corporation20260—