510(k) Report

Devices descending from K964760

908 later devices reach Dornier Medilas Fiber Tome Laser through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+9K100896Gyrus Acmi Halo PKS Cutting ForcepsGyrus Acmi, Inc.201031
+9K081766PKS Omni InstrumentGyrus-Acmi L.P.200831
+9K081954Gyrus Acmi General Surgery Workstation, Model G400, and Dual Footswitch Connector CableGyrus Acmi, Inc.20080—
+9K071759LTC Vad System, Models #Vad.400 (Electrosurgical Generator); PCS-900 and PCC-900 (Hand…Live Tissue Connect, Inc.20080—
+9K081542Modification to Entellus Medical RS-Series SystemEntellus Medical, Inc.200842—
+9K063538Arthrocare Controller (System 2000 and 8000), Arthrocare Patient Cable, Foot Control…Arthrocare Corp.200640—
+9K052692Suretek Medical Reprocessed Electrosurgical ElectrodesSuretek Medical20060—
+10K260945Ultima System (UL-800);Ultimate Face Package (UL-800-Face-Set);Ultimate Shape Extension…Fit-Pro KFT (Ltd.) - DBA E-Fit20260—
+10K261221SOLTIVE™ Laser System (SOLTIVE™ Pro SuperPulsed Laser, SOLTIVE™ Premium SuperPulsed…Olympus Surgical Technologies America20261—
+10K254056THUNDERBEAT 5 mm, 45 cm, Front-actuated Grip Type S (TB-0545FCS); THUNDERBEAT 5 mm, 35…Olympus Medical Systems Corp.20260—
+10K261701Hemolase 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—
+10K261570Picosure WorkstationCynosure, LLC20260—
+10K260138LUNE PureHygieneEnamel Pure20260—
+10K253951Holmium Laser Therapeutic Apparatus (HZ-A); Holmium Laser Therapeutic Apparatus (HZ-B)…Guangzhou Potent Medical Equipment Joint-Stock Co., Ltd.20260—
+10K251981Boston PICO (Boston PICO)Boston Aesthetics, Inc.20260—
+10K254290ZenTite (Unicorn+); ZenTite (Unicorn+I); ZenTite (Unicorn+II); ZenTite (Unicorn+III)Shenzhen Peninsula Medical Group20260—
+10K252369Boston Pico755Boston Aesthetics, Inc.20260—
+10K252771Holmium Laser System (Potent HP90); Holmium Laser System (Potent HP100); Holmium Laser…Guangzhou Potent Medical Equipment Joint-Stock Co., Ltd.20250—
+10K252345Picosecond Laser Device (PF131-BI)Risu Medical Technology Co., Ltd.20250—
+10K252150Ultrasonic Bipolar Generator (USG-410); Reuseable Cordless Transducer (TD-410)…Olympus Medical Systems Corporation202504
+10K251100Ipgtfl-02Ipg Medical Corporation20250—
+10K250504Leonardo DusterCeramoptec GmbH20250—
+10K243123IPL Treatment Device (MDSQMC-01)Medusa (Guangxi)Medical Devices Co., Ltd.20250—
+10K251230The Alma Hybrid Laser SystemAlma Lasers, Inc.20250—
+10K242755Medical Diode Laser Systems (VELAS II-30B, VELAS II-30A, GBOX-15AB, GBOX-20B, CHEESE…Gigaalaser Company, Ltd.20251—
+10K243176BLESSING SystemCellah Medical Co., Ltd.20251—
+10K250809Stellar M22Lumenis Be, Ltd.20250—
+10K243957PicoalexWontech Co., Ltd.20250—
+10K250281Deka LotusEl.En S.P.A.20250—
+10K250200InbellaBody SystemInbella Medical, Inc.20250—
+10K243929Oligio XWontech Co., Ltd.20250—
+10K242534HandPICO Fractional Laser Handpiece TipVydence Medical20241—
+10K231216PotenzaJeisys Medical, Inc.20244—
+10K231287PotenzaJeisys Medical, Inc.20241—
+10K241092Youlaser PRIME; Youlaser PRIME CO2; Youlaser PRIME MTQuanta System Spa20240—
+10K233123SilkroHironic Co., Ltd.20241—
+10K241407Splendor X (Alex, Alex2, Nd:YAG, Alex+Nd:YAG)Bios S.R.L.20240—
+10K233120CWM-930S, Fixer DV9Chungwoo Co., Ltd.20240—
+10K233099GladiatorRohrer Aesthetics, LLC20240—
+10K240386Picosecond Nd:YAG Laser Systems (BL-C10)Shanghai Bele Medical Technology Co.,Ltd20240—
+10K240999Legend X Applicator VOPollogen, Ltd.20241—
+10K240396Elite iQ PRO (M122K1)Cynosure, LLC20240—
+10K230837PlazMagikAgnes Medical Co., Ltd.20240—
+10K233143PiXel8-RevealRohrer Aesthetics20240—
+10K233147PiXel8-RFRohrer Aesthetics20230—
+10K232223PlaDuo SystemShenB Co., Ltd.20230—
+10K231777Electrosurgical Generator ESG-410 and Accessories (WA91327U, WA91327W), Accessories…Olympus Winter & Ibe GmbH202302
+10K231790The InMode System with the Morpheus8 ApplicatorsInMode, Ltd.202310—
+10K222790F65 Laser SystemLumenis Be, Ltd.20233—
+10K230373HELIOS 785 PicoLaseroptek Co., Ltd.20232—
+10K220322Pollogen STOP U Model UXV DevicePollogen, Ltd.20233—
+10K222260Capenergy C Equipment RF System - C25, C50, C100, C200, C300, C400, C500Capenergy Medical S.L.20233—
+10K222709Retraction, CWM-910T, APOLEX TiteChungwoo Co., Ltd.20230—
+10K222221Deka HelixEl.En Electronic Engineering Spa20231—
+10K220853PicoWay Laser SystemCandela Corporation20221—
+10K221770Fiber Laser Treatment SystemShanghai Apolo Medical Technology Co., Ltd.20221—
+10K214015Palm NRG cellulite body device (model: Palm NRG body device)Heat IN A Click, LLC20220—
+10K221407truSculpt iDCutera, Inc.20222—
+10K212472AgeJetTriworks Group Srl20220—
+10K211000AcutronIlooda Co,., Ltd.20220—
+10K212127PicocaremajestyWontech Co., Ltd.20226—
+10K201773PicohiHironic Co., Ltd.20215—
+10K211821DEKA Motus AZEl.En Electronic Engineering Spa20211—
+10K202884SR-1 Skin Treatment SystemAVAVA, Inc.20214—
+10K203491PicoLO Nd: YAG Picosecond Laser SystemLaseroptek Co., Ltd.20211—
+10K202199BTL-899STBtl20216—
+10K200427Sonicision Cordless Ultrasonic DissectorCovidien, LLC20200—
+10K200116PicoSecond Nd: YAG Laser SystemShanghai Apolo Medical Technology Co., Ltd.20206—
+10K201111GentleMax Pro PlusCandela Corporation20203—
+10K200110SANDRO DualWontech Co., Ltd.20202—
+10K191855EmFace DeviceInmode MD, Ltd.20191—
+10K190678TempSureCynosure, Inc.201914—
+10K183452Vbeam Prima Laser SystemCandela Corp.20191—
+10K182365TempSure SystemCynosure, Inc.201815—
+10K181095RF-ReliefEl Global Trade, Ltd.20181—
+10K173627Medline ReNewal Reprocessed Sonicision Cordless Ultrasonic DissectorSurgical Instrument Service and Savings, Inc.20180—
+10K180149Sonicision Reusable Generator, Sonicision Reusable Battery Pack, Sonicision Curved Jaw…Covidien, LLC201812
+10K173677InMode VLazeInmode MD, Ltd.20183—
+10K172302InMode PLUS SystemInmode MD, Ltd.201713—
+10K171711Thunder, Thunder VT, Thunder HRQuanta System Spa20170—
+10K170116Thermi Injectable RF ElectrodesThermi20172—
+10K163190InMode RF SystemInmode MD, Ltd.20160—
+10K163222Discovery Pico FamilyQuanta System Spa201630—
+10K161825PK AIMGyrus Acmi, Inc.20162—
+10K161162Frax 1550 for Ellipse Nordlys/ Ellipse Nordlys+, Ellipse Sirius, Ellipse Infinity…Ellipse A/S20164—
+10K142759PK Cutting Forceps for ESG-400 WorkstationGyrus Acmi, Inc.20152—
+10K102003Xpress Balloon DeviceEntellus Medical, Inc.201036—
+10K093007Entellus Medical Balloon DeviceEntellus Medical, Inc.201041—
+11K262877SOLTIVE™ Laser System (SOLTIVE™ Pro SuperPulsed Laser, SOLTIVE™ Premium SuperPulsed…Olympus Surgical Technologies America20260—
+11K254185Potenza PrimeJeisys Medical Incorporated20260—
+11K2618211565nm Laser Therapy Device (PZ-JG86-01,PZ-JG86-02)Zhengzhou PZ Laser Slim Technology Co., Ltd.20260—
+11K253859Scarlet Pro (Scarlet Pro)VIOL Co., Ltd.20260—
+11K253484Lutronic GeniusCynosure Lutronic Technology Corporation20260—
+11K253803MILAN SystemLumenis Be, Ltd.20260—
+11K260017Picosecond Nd:YAG Laser Systems (Model: HS-298)Shanghai Apolo Medical Technology Co., Ltd.20260—
+11K253965CureLight Medical Diode Laser Systems (CureLight F2-A15; CureLight F2-B15; CureLight…Wuhan PHOMED Technology Company, Ltd.20260—
+11K253828Medical Alexandrite and Nd:YAG laser Therapy System (CM11LP)Beijing HuaCheng Taike Technology Co., Ltd.20260—
+11K253829Medical Ultra-Pico Laser Treatment System (CM-SP-1064&532)Beijing HuaCheng Taike Technology Co., Ltd.20260—
+11K251435InbellaIgnite RF SystemInbella Medical, Inc.20260—
+11K252753Vydence Family of LasersVydence Medical Industria E Commercio Ltda20260—