510(k) Report

Devices descending from K974381

1,178 later devices reach Candela Gentlelase GL Dermatological Laser through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+11K200947InMode System with the Morhpeus8 ApplicatorsInMode, Ltd.202015—
+11K193486Epic 980Biolase, Inc.20202—
+11K200234Surgical laser fibersQuanta System Spa20202—
+11K181614Sterling Supreme Diode LaserCAO Group, Inc.20190—
+11K180044SIROLaser BlueDentsply Sirona201812—
+11K171992SculpSureCynosure, Inc.20178—
+11K171069ZELTIQ CoolSculpting SystemZeltiq Aesthetics, Inc.20178—
+11K163197Cook Holmium Laser FiberCook Incorporated20170—
+11K163128Epic ProBiolase, Inc.201716—
+11K160513Quanta System Surgical Laser fibersQuanta System Spa201631
+11K152417Adler MicroMed Laser Surgery FibersAdler Micromed, Inc.20153—
+11K122020Photon Photon PlusZolar Technology & Mfg Co., Inc.20134—
+12K253542Apollo Quattro (APQ-10M)Weero Co., Ltd.20260—
+12K254290ZenTite (Unicorn+); ZenTite (Unicorn+I); ZenTite (Unicorn+II); ZenTite (Unicorn+III)Shenzhen Peninsula Medical Group20260—
+12K250731MateLaser Medical Diode Laser Systems (ML-DLS-30)Matelaser, Inc.20250—
+12K251334New Doublo 2.0Hironic Co., Ltd.20250—
+12K241433EVE Synergy (EVE-20M)Weero Co., Ltd.20251—
+12K243176BLESSING SystemCellah Medical Co., Ltd.20251—
+12K243764Medical Diode Laser (UTU3-F7B,UTU3-F7W,UTU3-G7B,UTU3-G7W,UTU-G20B,UTU-G20W)Wuhan Pioon Technology Co., Ltd.20250—
+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—
+12K231287PotenzaJeisys Medical, Inc.20241—
+12K240992eMVFit (MVF-10M)Weero Co., Ltd.20240—
+12K2406581060nm laser body slimming machineHebei JT Medical Co., Ltd.20240—
+12K240999Legend X Applicator VOPollogen, Ltd.20241—
+12K233849BTL-499BTL Industries, Inc.20240—
+12K233604BTL-785SBTL Industries, Inc.20243—
+12K234085LUNE™ PureHygieneEnamel Pure20241—
+12K230047Medical Diode Laser SystemsGigaalaser Company, Ltd.20242—
+12K230837PlazMagikAgnes Medical Co., Ltd.20240—
+12K232769BeaMed Laser Surgery FibersBt Beamedical Tachnoogies Ltd. (Beamed)20231—
+12K232223PlaDuo SystemShenB Co., Ltd.20230—
+12K231971Deka Physiq 360El.En S.P.A.20230—
+12K230167BACK 4Swims America Corp20230—
+12K231790The InMode System with the Morpheus8 ApplicatorsInMode, Ltd.202310—
+12K230037BACK 3Swims America Corp20230—
+12K230819OmniGuide RFID Surgical Laser FibersOmni-Guide Holdings, Inc.20230—
+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—
+12K212472AgeJetTriworks Group Srl20220—
+12K213726PL-1 Skin Treatment SystemAVAVA, Inc.20220—
+12K220793InnoVoyce Laser FiberInnovoyce, LLC20220—
+12K220592Venus BlissMAXVenus Concept USA, Inc.20221—
+12K210350Gemini 2 810+980 Soft Tissue LaserAzena Medical, LLC20211—
+12K201387Ultrafast, Ultrafast Plus, Ultrafast LiteDentlight, Inc.20210—
+12K182741SculpSureCynosure20195—
+12K172771Epic Pro 940Biolase, Inc.20171—
+12K172144CoolSculpting SystemZeltiq Aesthetics20177—
+12K161403A.R.C. Laser Surgical Fibers and ProbesA.R.C Laser GmbH20160—
+13K254185Potenza PrimeJeisys Medical Incorporated20260—
+13K253859Scarlet Pro (Scarlet Pro)VIOL Co., Ltd.20260—
+13K253484Lutronic GeniusCynosure Lutronic Technology Corporation20260—
+13K253803MILAN SystemLumenis Be, Ltd.20260—
+13K260138LUNE PureHygieneEnamel Pure20260—
+13K253750BTL-785NEHBTL Industries, Inc.20260—
+13K260765Gemini NOVA 810+980 Soft Tissue LaserAzena Medical, LLC20260—
+13K251435InbellaIgnite RF SystemInbella Medical, Inc.20260—
+13K251254Ignite RF SystemInMode, Ltd.20260—
+13K252745Halo Sterile Single-use Radial Fiber…Micro-Energy Medical Technology Co., Ltd.20251—
+13K253007Laser 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—
+13K252845Venus Nova (FP-2001)Venus Concept, Inc.20250—
+13K252367InbellaMulti SystemInbella Medical, Inc.20250—
+13K242755Medical Diode Laser Systems (VELAS II-30B, VELAS II-30A, GBOX-15AB, GBOX-20B, CHEESE…Gigaalaser Company, Ltd.20251—
+13K242469RFMagik LiteAgnes Medical Co., Ltd.20252—
+13K250113neoLaser Laser Surgery FibersG.N.S Neolaser, Ltd.20250—
+13K242532BTL-785BNF-EBTL Industries, Inc.20241—
+13K233642InMode RF SystemInMode, Ltd.20244—
+13K231131Diode Laser Body Sculpture SystemsShanghai Bele Medical Technology Co.,Ltd20230—
+13K181740ZELTIQ CoolSculpting SystemZeltiq Aesthetics, Inc.201805
+14K261701Hemolase Fiber (Hemo-R-0.40-2.5/Hemo-R-0.60-2.5/Hemo-R-0.40-1.8/Hemo-R-0.60-1.8)Micro-Energy Medical Technology Co., Ltd.20260—
+14K253965CureLight Medical Diode Laser Systems (CureLight F2-A15; CureLight F2-B15; CureLight…Wuhan PHOMED Technology Company, Ltd.20260—
+14K250217AGNES UltraAgnes Medical Co., Ltd.20250—
+14K243713Single Use RF Surgical Electrode (Needle Type) (AN-B, AN-C, AN-E, AN-I, AN-S, AN-W3A…Agnes Medical Co., Ltd.20250—
+14K240780InMode RF SystemInMode, Ltd.20243—
+15K243737Inbella RF SystemInbella Medical, Inc.20250—