510(k) Report

Devices descending from K961748

1,230 later devices reach Medlite/Erbium Laser System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+10K172002Catalys Precision Laser SystemAmo Manufacturing USA, LLC201751
+10K163197Cook Holmium Laser FiberCook Incorporated20170—
+10K160470SculpSureCynosure, Inc.201620—
+10K160259ZELTIQ CoolSculpting SystemZeltiq Aesthetics, Inc.201615—
+10K160513Quanta System Surgical Laser fibersQuanta System Spa201631
+10K152417Adler MicroMed Laser Surgery FibersAdler Micromed, Inc.20153—
+10K151629Guardian 1000Quanta System Spa20150—
+10K150724SculpSureCynosure, Inc.201521—
+10K150230SculpSureCynosure, Inc.201521—
+10K131059Pioneer Elite Diode LaserCAO Group, Inc.20132—
+10K123443Precise SHP Diode LaserCAO Group, Inc.20139—
+10K121286EPIC 10Biolase Technology, Inc.201231—
+10K110243Medart Diode Laser System & AccessoriesMedart A/S20110—
+10K094049Stlase Diode LaserDental Photonics, Inc.201023—
+10K091562Doctor Smile a-810 and B-980 LasersLambda Scientific Spa20098—
+10K082263Ceralas E 980NM Diode Laser, Models E15/980 and E30/980Biolitec, Inc.20081—
+11K261602Eye Recovery Pro (PH-e03)Shenzhen Goodwind Technology Development Co., Ltd.20260—
+11K261601LED Light Therapy Mask (M01, M02, M03, M05, M06, M07, M08)Shenzhen Chuangtong Yigou Technology Co., Ltd.20260—
+11K261407XPREEN LED Light Therapy Masks (XPRE322, XPRE326, XPRE327, XPRE342, XPRE368, XPRE422…Dongguan Miqiang Technology Co., Ltd.20260—
+11K261052LED Light Therapy Masks (LED Face Mask Pro FAC08NA, LED Chest Mask Pro FAC09NA)Guangdong Newdermo Biotech Co., Ltd.20260—
+11K260946LED Light Therapy Mask (K9C-TK, K9C-K, K9P-YK, K9P-K, FM-03BK, FM-09K)Guangdong Newdermo Biotech Co., Ltd.20260—
+11K254079LED Light Therapy Mask (Models: T2, RLD10)Shenzhen Desida Technology Co., Ltd.20260—
+11K253086LED Light Therapy Device (Models: SG-FM, SG-FE)Sunglor Technology Co., Ltd.20250—
+11K252308LED Beauty Mask (RLBXX)Atop Lighting Co., Ltd.20250—
+11K2527321927nm Thulium Laser System (PZ-DJG75-01, PZ-DJG75-02)Zhengzhou PZ Laser Slim Technology Co., Ltd.20251—
+11K252264MEGELIN LED Light Therapy Mask (JML1, JML1+JML2); MEGELIN LED Light Therapy Mask (JML3…Shenzhen Zhenxing Ruitong Technology Co., Ltd.20252—
+11K252093Light Therapy Mask (1019055)Merchsource, LLC20250—
+11K250217AGNES UltraAgnes Medical Co., Ltd.20250—
+11K243713Single Use RF Surgical Electrode (Needle Type) (AN-B, AN-C, AN-E, AN-I, AN-S, AN-W3A…Agnes Medical Co., Ltd.20250—
+11K250581KALA Red Light Face Mask (KALA-01)Shenzhen Kaiyan Medical Equipment Co., Ltd.20250—
+11K241643WONTECH Surgical Optic Fibers (BA400/BA400R/BA600/BA600R)Wontech Co., Ltd.20252—
+11K242941CO2 Laser Therapy Systems (SHE-LSP003-1)Beijing Sano Laser S&T Development Co.,Ltd20250—
+11K243147LGO-Surgical Laser FibersLight Guide Optics International, Ltd.20241—
+11K242382décoLITE LED DeviceiSMART Developments, Ltd.20246—
+11K240991eMVFit (MVF-10M)Weero Co., Ltd.20240—
+11K240780InMode RF SystemInMode, Ltd.20243—
+11K232769BeaMed Laser Surgery FibersBt Beamedical Tachnoogies Ltd. (Beamed)20231—
+11K232532Nd:Yag Laser Therapy SystemsBeijing Unt Technology Co., Ltd.20230—
+11K230351LED Facial MaskShenzhen Sungpo Hi-Tech Electronic Co., Ltd.202333—
+11K230819OmniGuide RFID Surgical Laser FibersOmni-Guide Holdings, Inc.20230—
+11K221775LED Light Therapy Mask (model: MK-78, MK-04, MK66-H, MK66R-B, EL00003)Light Tree Ventures Europe B.V.20227—
+11K221946LED Light Therapy Mask (model: MK66R-B)Light Tree Ventures Europe B.V.202218—
+11K221151Beauty LED Mask, Model: KFB265Hunan Guangye Biotechnology Co., Ltd.202241—
+11K220793InnoVoyce Laser FiberInnovoyce, LLC20220—
+11K213889PicoStarAsclepion Laser Technologies GmbH20220—
+11K211681EONDominion Aesthetic Technologies, Inc.20221—
+11K213184MZ Skin LightMAX Supercharged LED Mask 2.0Mz Skin202135—
+11K210877Evolve System with the T3 ApplicatorInMode, Ltd.20215—
+11K201285InMode Evolve System with the Tone ApplicatorInMode, Ltd.20216—
+11K192430Epic 980Biolase, Inc.20195—
+11K191842Discovery Pico, Discovery Pico Plus, Discovery Pico DermQuanta System Spa201918—
+11K181602Pioneer Elite Diode LaserCAO Group, Inc.20190—
+11K181601Precise SHP Diode LaserCAO Group, Inc.20191—
+11K191068Powersculp laser lipolysis systemWuhan Lotuxs Technology Co., Ltd.20196—
+11K190743Venus BlissVenus Concept USA, Inc.20194—
+11K182083Catalys Precision Laser SystemAmo Manufacturing USA, LLC20184—
+11K180967Dental Diode Laser SystemLazon Medical Laser Co., Ltd.20180—
+11K171986Sterling Supreme Diode LaserCAO Group, Inc.20171—
+11K171111SculpsureCynosure, Inc.201710—
+11K170500SIROLaser Advance+Dentsply Sirona201721—
+11K162114Photon, Photon PlusZolar Technology & Mfg Co., Inc.20163—
+11K162050ZELTIQ CoolSculpting SystemZeltiq Aesthetics, Inc.201614—
+11K161403A.R.C. Laser Surgical Fibers and ProbesA.R.C Laser GmbH20160—
+11K142226Pilot Ultra Diode LaserCAO Group, Inc.20140—
+11K142225Pilot Elite Diode LaserCAO Group, Inc.20140—
+11K111689StlaseDental Photonics, Inc.201222—
+12K261047Dental Diode Laser Device (Laser-Pen)Guilin Kevin Peter Technology Co., Ltd.20260—
+12K2615891927nm Thulium Laser System (PZ-DJG85-01, PZ-DJG85-02)Zhengzhou PZ Laser Slim Technology Co., Ltd.20260—
+12K261851LED Light Therapy Mask (JML1, JML1+JML2); LED Light Therapy Mask (JML3, JML3+JML4); LED…Shenzhen Qianyu Technology Co., Ltd.20260—
+12K253542Apollo Quattro (APQ-10M)Weero Co., Ltd.20260—
+12K252745Halo Sterile Single-use Radial Fiber…Micro-Energy Medical Technology Co., Ltd.20251—
+12K253007Laser 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—
+12K252096Light Therapy Decollete Mask (1019135)Merchsource, LLC20250—
+12K250966CurrentBody Skin™ LED Light Therapy Mask Series 2 (MK-90H)Shenzhen Kaiyan Medical Equipment Co., Ltd.20250—
+12K241433EVE Synergy (EVE-20M)Weero Co., Ltd.20251—
+12K242068LED Light Therapy Mask (RT01)Ningbo Dechang Electrical Machinery Made Co.,Ltd20250—
+12K250113neoLaser Laser Surgery FibersG.N.S Neolaser, Ltd.20250—
+12K243737Inbella RF SystemInbella Medical, Inc.20250—
+12K243040LED Light Therapy Mask…Shenzhen Siken 3D Technology Development Co., Ltd.20241—
+12K240992eMVFit (MVF-10M)Weero Co., Ltd.20240—
+12K233962ReBorn (1050nm)Lightfective, Ltd.20240—
+12K233114LED silicone mask (Model: LP-RVTGLWP-WHT, LP-RVTGLW-WHT, TLM200)Shenzhen Idea Light Limited20241—
+12K232222Primo Dental Laser (Primo, Primo Komfort, Primo Lite, Primo Blue, and Primo Triplo)Medency S.R.L.20230—
+12K230167BACK 4Swims America Corp20230—
+12K230037BACK 3Swims America Corp20230—
+12K222226EONDominion Aesthetic Technologies, Inc.20230—
+12K222265DiosculptShanghai Wonderful Opto-Electrics Tech.Co.,Ltd20220—
+12K214103Shani Darden LED light therapy maskHarpar Grace International202219—
+12K210367D-Laser Blue, D-Laser 16Guilin Woodpecker Medical Instrument Co., Ltd.20226—
+12K213308Venus BlissMAXVenus Concept USA, Inc.20222—
+12K212331BodySculpRohrer Aesthetics, LLC20211—
+12K211402Powersculp laser lipolysis systemLotuxs Medtech (Suzhou) Co., Ltd.20210—
+12K192970SlimusHironic Co., Ltd.20200—
+12K200693K2 MobileHulaser, Inc.20202—
+12K202503ChromeQuanta System Spa202012—
+12K201731Diode Laser Body Sculpture SystemShanghai Apolo Medical Technology Co., Ltd.20201—
+12K200056Catalys Precision Laser SystemAmo Manufacturng USA, LLC20203—
+12K193486Epic 980Biolase, Inc.20202—
+12K181614Sterling Supreme Diode LaserCAO Group, Inc.20190—
+12K180044SIROLaser BlueDentsply Sirona201812—