510(k) Report

Devices descending from K011092

1,127 later devices reach Candela SPTL-1E Pulsed Dye Laser through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+10K251988Boston iFace (Boston iFace)Boston Aesthetics, Inc.20260—
+10K250776Lithoblast Single Use Holmium Laser FibersDawell Medical, LLC20250—
+10K252096Light Therapy Decollete Mask (1019135)Merchsource, LLC20250—
+10K250966CurrentBody Skin™ LED Light Therapy Mask Series 2 (MK-90H)Shenzhen Kaiyan Medical Equipment Co., Ltd.20250—
+10K242068LED Light Therapy Mask (RT01)Ningbo Dechang Electrical Machinery Made Co.,Ltd20250—
+10K241832Unicorn+ RF System (Unicorn+); Unicorn+ RF System (Unicorn+ I); Unicorn+ RF System…Boston Aesthetics, Inc.20251—
+10K243040LED Light Therapy Mask…Shenzhen Siken 3D Technology Development Co., Ltd.20241—
+10K241670Fractional CO2 Laser Therapy System (FG900-S); Fractional CO2 Laser Therapy System…Beijing Adss Development Co., Ltd.20241—
+10K240991eMVFit (MVF-10M)Weero Co., Ltd.20240—
+10K233123SilkroHironic Co., Ltd.20241—
+10K233120CWM-930S, Fixer DV9Chungwoo Co., Ltd.20240—
+10K233099GladiatorRohrer Aesthetics, LLC20240—
+10K233157VaporMAX LDD; MOJo LDD; MegaJOULE LDDInnovaquartz, LLC20240—
+10K222958mJOULE RF System and AccessoriesSciton, Inc20240—
+10K233114LED silicone mask (Model: LP-RVTGLWP-WHT, LP-RVTGLW-WHT, TLM200)Shenzhen Idea Light Limited20241—
+10K232106Air Gap FiberWontech Co., Ltd.20240—
+10K232222Primo Dental Laser (Primo, Primo Komfort, Primo Lite, Primo Blue, and Primo Triplo)Medency S.R.L.20230—
+10K233147PiXel8-RFRohrer Aesthetics20230—
+10K222556BTL-785XBTL Industries, Inc.20235—
+10K221574LUDWIG Electrosurgical DeviceAesthetics Biomedical20220—
+10K211000AcutronIlooda Co,., Ltd.20220—
+10K220189LISA Laser Surgical FibersOmni-Guide Holdings, Inc.20225—
+10K214103Shani Darden LED light therapy maskHarpar Grace International202219—
+10K210367D-Laser Blue, D-Laser 16Guilin Woodpecker Medical Instrument Co., Ltd.20226—
+10K220124YandR System, VoluDerm Handpiece, VoluDerm TipsPollogen, Ltd.20220—
+10K210877Evolve System with the T3 ApplicatorInMode, Ltd.20215—
+10K201171LEONI Laser Fibers: BareFiber Disposable, BareFiber Reusable and Endoprobe DisposableLeoni Fiber Optics, Inc.20210—
+10K201285InMode Evolve System with the Tone ApplicatorInMode, Ltd.20216—
+10K201685PotenzaJeisys Medical, Inc.20219—
+10K201735PlaDuo SystemShenB Co., Ltd.20203—
+10K200693K2 MobileHulaser, Inc.20202—
+10K202503ChromeQuanta System Spa202012—
+10K200947InMode System with the Morhpeus8 ApplicatorsInMode, Ltd.202015—
+10K193486Epic 980Biolase, Inc.20202—
+10K200234Surgical laser fibersQuanta System Spa20202—
+10K181614Sterling Supreme Diode LaserCAO Group, Inc.20190—
+10K180044SIROLaser BlueDentsply Sirona201812—
+10K163197Cook Holmium Laser FiberCook Incorporated20170—
+10K163128Epic ProBiolase, Inc.201716—
+10K160470SculpSureCynosure, Inc.201620—
+10K160259ZELTIQ CoolSculpting SystemZeltiq Aesthetics, Inc.201615—
+10K160513Quanta System Surgical Laser fibersQuanta System Spa201631
+10K152417Adler MicroMed Laser Surgery FibersAdler Micromed, Inc.20153—
+10K150724SculpSureCynosure, Inc.201521—
+10K150230SculpSureCynosure, Inc.201521—
+10K122020Photon Photon PlusZolar Technology & Mfg Co., Inc.20134—
+11K253542Apollo Quattro (APQ-10M)Weero Co., Ltd.20260—
+11K254290ZenTite (Unicorn+); ZenTite (Unicorn+I); ZenTite (Unicorn+II); ZenTite (Unicorn+III)Shenzhen Peninsula Medical Group20260—
+11K250731MateLaser Medical Diode Laser Systems (ML-DLS-30)Matelaser, Inc.20250—
+11K251334New Doublo 2.0Hironic Co., Ltd.20250—
+11K241433EVE Synergy (EVE-20M)Weero Co., Ltd.20251—
+11K243176BLESSING SystemCellah Medical Co., Ltd.20251—
+11K243764Medical Diode Laser (UTU3-F7B,UTU3-F7W,UTU3-G7B,UTU3-G7W,UTU-G20B,UTU-G20W)Wuhan Pioon Technology 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—
+11K242688Finiff SystemSkingrab Co., Ltd.20240—
+11K231216PotenzaJeisys Medical, Inc.20244—
+11K231287PotenzaJeisys Medical, Inc.20241—
+11K240992eMVFit (MVF-10M)Weero Co., Ltd.20240—
+11K240999Legend X Applicator VOPollogen, Ltd.20241—
+11K233849BTL-499BTL Industries, Inc.20240—
+11K233604BTL-785SBTL Industries, Inc.20243—
+11K234085LUNE™ PureHygieneEnamel Pure20241—
+11K230047Medical Diode Laser SystemsGigaalaser Company, Ltd.20242—
+11K230837PlazMagikAgnes Medical Co., Ltd.20240—
+11K232769BeaMed Laser Surgery FibersBt Beamedical Tachnoogies Ltd. (Beamed)20231—
+11K232223PlaDuo SystemShenB Co., Ltd.20230—
+11K230167BACK 4Swims America Corp20230—
+11K231790The InMode System with the Morpheus8 ApplicatorsInMode, Ltd.202310—
+11K230037BACK 3Swims America Corp20230—
+11K230819OmniGuide RFID Surgical Laser FibersOmni-Guide Holdings, Inc.20230—
+11K230124LUSTRE ClearSkin Renew Pro Facewear Mask (Model: PR4001)Light Tree Ventures Europe B.V.202310—
+11K223404Duetto Suprema; Domino Suprema; Suprema VT; Suprema VT+; Suprema 4VQuanta System Spa20230—
+11K212472AgeJetTriworks Group Srl20220—
+11K213726PL-1 Skin Treatment SystemAVAVA, Inc.20220—
+11K220793InnoVoyce Laser FiberInnovoyce, LLC20220—
+11K211681EONDominion Aesthetic Technologies, Inc.20221—
+11K210350Gemini 2 810+980 Soft Tissue LaserAzena Medical, LLC20211—
+11K201387Ultrafast, Ultrafast Plus, Ultrafast LiteDentlight, Inc.20210—
+11K191068Powersculp laser lipolysis systemWuhan Lotuxs Technology Co., Ltd.20196—
+11K190743Venus BlissVenus Concept USA, Inc.20194—
+11K172771Epic Pro 940Biolase, Inc.20171—
+11K171111SculpsureCynosure, Inc.201710—
+11K162050ZELTIQ CoolSculpting SystemZeltiq Aesthetics, Inc.201614—
+11K161403A.R.C. Laser Surgical Fibers and ProbesA.R.C Laser GmbH20160—
+12K254185Potenza PrimeJeisys Medical Incorporated20260—
+12K253859Scarlet Pro (Scarlet Pro)VIOL Co., Ltd.20260—
+12K253484Lutronic GeniusCynosure Lutronic Technology Corporation20260—
+12K253803MILAN SystemLumenis Be, Ltd.20260—
+12K260138LUNE PureHygieneEnamel Pure20260—
+12K253750BTL-785NEHBTL Industries, Inc.20260—
+12K260765Gemini NOVA 810+980 Soft Tissue LaserAzena Medical, LLC20260—
+12K251435InbellaIgnite RF SystemInbella Medical, Inc.20260—
+12K251254Ignite RF SystemInMode, 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—
+12K252367InbellaMulti SystemInbella Medical, Inc.20250—
+12K242755Medical Diode Laser Systems (VELAS II-30B, VELAS II-30A, GBOX-15AB, GBOX-20B, CHEESE…Gigaalaser Company, Ltd.20251—
+12K242469RFMagik LiteAgnes Medical Co., Ltd.20252—