510(k) Report

Devices descending from K933880

1,212 later devices reach SL Series Surgical Laser Systems through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+10K231287PotenzaJeisys Medical, Inc.20241—
+10K233123SilkroHironic Co., Ltd.20241—
+10K241459MOTUS PRO FamilyEl.En S.P.A.20240—
+10K233120CWM-930S, Fixer DV9Chungwoo Co., Ltd.20240—
+10K233099GladiatorRohrer Aesthetics, LLC20240—
+10K240999Legend X Applicator VOPollogen, Ltd.20241—
+10K233849BTL-499BTL Industries, Inc.20240—
+10K233604BTL-785SBTL Industries, Inc.20243—
+10K230837PlazMagikAgnes Medical Co., Ltd.20240—
+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—
+10K221151Beauty LED Mask, Model: KFB265Hunan Guangye Biotechnology Co., Ltd.202241—
+10K212472AgeJetTriworks Group Srl20220—
+10K211000AcutronIlooda Co,., Ltd.20220—
+10K213889PicoStarAsclepion Laser Technologies GmbH20220—
+10K213184MZ Skin LightMAX Supercharged LED Mask 2.0Mz Skin202135—
+10K201387Ultrafast, Ultrafast Plus, Ultrafast LiteDentlight, Inc.20210—
+10K192430Epic 980Biolase, Inc.20195—
+10K191842Discovery Pico, Discovery Pico Plus, Discovery Pico DermQuanta System Spa201918—
+10K183450EmBody SystemInmode MD, Ltd.20198—
+10K180967Dental Diode Laser SystemLazon Medical Laser Co., Ltd.20180—
+10K173359Fractional CO2 Surgical Laser SystemAmi, Inc.20180—
+10K170500SIROLaser Advance+Dentsply Sirona201721—
+10K151179ZELTIQ CoolSculpting SystemZeltiq Aesthetics, Inc.201526—
+10K142491ZEL TIQ CoolSculpting SystemZeltiq Aesthetics, Inc.201527—
+10K133212Zeltiq Coolsculpting SystemZeltiq Aesthetics, Inc.201430—
+10K111689StlaseDental Photonics, Inc.201222—
+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—
+11K253803MILAN SystemLumenis Be, Ltd.20260—
+11K253750BTL-785NEHBTL Industries, Inc.20260—
+11K251435InbellaIgnite RF SystemInbella Medical, Inc.20260—
+11K251254Ignite RF SystemInMode, Ltd.20260—
+11K252367InbellaMulti SystemInbella Medical, Inc.20250—
+11K252096Light Therapy Decollete Mask (1019135)Merchsource, LLC20250—
+11K251334New Doublo 2.0Hironic Co., Ltd.20250—
+11K250966CurrentBody Skin™ LED Light Therapy Mask Series 2 (MK-90H)Shenzhen Kaiyan Medical Equipment Co., Ltd.20250—
+11K242469RFMagik LiteAgnes Medical Co., Ltd.20252—
+11K242068LED Light Therapy Mask (RT01)Ningbo Dechang Electrical Machinery Made Co.,Ltd20250—
+11K242941CO2 Laser Therapy Systems (SHE-LSP003-1)Beijing Sano Laser S&T Development Co.,Ltd20250—
+11K243040LED Light Therapy Mask…Shenzhen Siken 3D Technology Development Co., Ltd.20241—
+11K242532BTL-785BNF-EBTL Industries, Inc.20241—
+11K240991eMVFit (MVF-10M)Weero Co., Ltd.20240—
+11K233642InMode RF SystemInMode, Ltd.20244—
+11K233114LED silicone mask (Model: LP-RVTGLWP-WHT, LP-RVTGLW-WHT, TLM200)Shenzhen Idea Light Limited20241—
+11K232222Primo Dental Laser (Primo, Primo Komfort, Primo Lite, Primo Blue, and Primo Triplo)Medency S.R.L.20230—
+11K214103Shani Darden LED light therapy maskHarpar Grace International202219—
+11K210367D-Laser Blue, D-Laser 16Guilin Woodpecker Medical Instrument Co., Ltd.20226—
+11K210877Evolve System with the T3 ApplicatorInMode, Ltd.20215—
+11K201285InMode Evolve System with the Tone ApplicatorInMode, Ltd.20216—
+11K202503ChromeQuanta System Spa202012—
+11K193486Epic 980Biolase, Inc.20202—
+11K180044SIROLaser BlueDentsply Sirona201812—
+11K163128Epic ProBiolase, Inc.201716—
+11K160470SculpSureCynosure, Inc.201620—
+11K160259ZELTIQ CoolSculpting SystemZeltiq Aesthetics, Inc.201615—
+11K150724SculpSureCynosure, Inc.201521—
+11K150230SculpSureCynosure, Inc.201521—
+11K122020Photon Photon PlusZolar Technology & Mfg Co., Inc.20134—
+12K253542Apollo Quattro (APQ-10M)Weero Co., Ltd.20260—
+12K250731MateLaser Medical Diode Laser Systems (ML-DLS-30)Matelaser, Inc.20250—
+12K250217AGNES UltraAgnes Medical Co., Ltd.20250—
+12K243713Single Use RF Surgical Electrode (Needle Type) (AN-B, AN-C, AN-E, AN-I, AN-S, AN-W3A…Agnes Medical Co., Ltd.20250—
+12K241433EVE Synergy (EVE-20M)Weero Co., Ltd.20251—
+12K243764Medical Diode Laser (UTU3-F7B,UTU3-F7W,UTU3-G7B,UTU3-G7W,UTU-G20B,UTU-G20W)Wuhan Pioon Technology Co., Ltd.20250—
+12K240992eMVFit (MVF-10M)Weero Co., Ltd.20240—
+12K240780InMode RF SystemInMode, Ltd.20243—
+12K234085LUNE™ PureHygieneEnamel Pure20241—
+12K230047Medical Diode Laser SystemsGigaalaser Company, Ltd.20242—
+12K230167BACK 4Swims America Corp20230—
+12K230037BACK 3Swims America Corp20230—
+12K230124LUSTRE ClearSkin Renew Pro Facewear Mask (Model: PR4001)Light Tree Ventures Europe B.V.202310—
+12K223404Duetto Suprema; Domino Suprema; Suprema VT; Suprema VT+; Suprema 4VQuanta System Spa20230—
+12K213726PL-1 Skin Treatment SystemAVAVA, Inc.20220—
+12K211681EONDominion Aesthetic Technologies, Inc.20221—
+12K210350Gemini 2 810+980 Soft Tissue LaserAzena Medical, LLC20211—
+12K191068Powersculp laser lipolysis systemWuhan Lotuxs Technology Co., Ltd.20196—
+12K190743Venus BlissVenus Concept USA, Inc.20194—
+12K172771Epic Pro 940Biolase, Inc.20171—
+12K171111SculpsureCynosure, Inc.201710—
+12K162050ZELTIQ CoolSculpting SystemZeltiq Aesthetics, Inc.201614—
+13K260138LUNE PureHygieneEnamel Pure20260—
+13K260765Gemini NOVA 810+980 Soft Tissue LaserAzena Medical, LLC20260—
+13K242755Medical Diode Laser Systems (VELAS II-30B, VELAS II-30A, GBOX-15AB, GBOX-20B, CHEESE…Gigaalaser Company, Ltd.20251—
+13K243737Inbella RF SystemInbella Medical, Inc.20250—
+13K233962ReBorn (1050nm)Lightfective, Ltd.20240—
+13K222226EONDominion Aesthetic Technologies, Inc.20230—
+13K222265DiosculptShanghai Wonderful Opto-Electrics Tech.Co.,Ltd20220—
+13K213308Venus BlissMAXVenus Concept USA, Inc.20222—
+13K212331BodySculpRohrer Aesthetics, LLC20211—
+13K211402Powersculp laser lipolysis systemLotuxs Medtech (Suzhou) Co., Ltd.20210—
+13K192970SlimusHironic Co., Ltd.20200—