510(k) Report

Devices descending from K955758

701 later devices reach Indigo Medical Model Idl 830E through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+9K222958mJOULE RF System and AccessoriesSciton, Inc20240—
+9K233757TitanPico Laser Workstation (PICO-450)Rhein Laser Technologies Co., Ltd.20240—
+9K234085LUNE™ PureHygieneEnamel Pure20241—
+9K230047Medical Diode Laser SystemsGigaalaser Company, Ltd.20242—
+9K240313Oligio XWontech Co., Ltd.20241—
+9K231896Diode Laser Therapy SystemBeijing Adss Development Co., Ltd.20240—
+9K232769BeaMed Laser Surgery FibersBt Beamedical Tachnoogies Ltd. (Beamed)20231—
+9K233090DEKA AGAIN PRO familyEl.En S.P.A.20232—
+9K231495The Evolve System with the Transform ApplicatorInMode, Ltd.20231—
+9K231092T-Shape 2B&M S.R.L. Marketing Nel Benessere20230—
+9K232192Venus Versa PRO SystemVenus Concept, Inc.20230—
+9K230819OmniGuide RFID Surgical Laser FibersOmni-Guide Holdings, Inc.20230—
+9K221574LUDWIG Electrosurgical DeviceAesthetics Biomedical20220—
+9K213120OW100S (model OW100S-US)Tissue Regeneration Technologies, LLC Dba AS Softwave Trt20220—
+9K212663Helios IV 785Laseroptek Co., Ltd.20223—
+9K210084SilkroHironic Co., Ltd.20223—
+9K220793InnoVoyce Laser FiberInnovoyce, LLC20220—
+9K220592Venus BlissMAXVenus Concept USA, Inc.20221—
+9K220124YandR System, VoluDerm Handpiece, VoluDerm TipsPollogen, Ltd.20220—
+9K202848S2 Pigment Removal SystemLightsense Technologies, Ltd.20210—
+9K212107ReversoIntelis Instruments, Ltd.20211—
+9K203441The Alma Hybrid Laser SystemAlma Lasers, Ltd.20215—
+9K210226PicoSure WorkstationCynosure, LLC20213—
+9K203665STOP U Model UXV DevicePollogen, Ltd.20214—
+9K201685PotenzaJeisys Medical, Inc.20219—
+9K201735PlaDuo SystemShenB Co., Ltd.20203—
+9K200947InMode System with the Morhpeus8 ApplicatorsInMode, Ltd.202015—
+9K192350Medical Non-Ablative Fractional Laser SystemsWingderm Electro-Optics, Ltd.202021
+9K193426Elite iQCynosure, LLC20201—
+9K192583PicoLazer Laser SystemRohrer Aesthetics, LLC20200—
+9K193500Stellar M22 for Intense Pulsed Light (IPL) and Laser SystemLumenis, Ltd.202012—
+9K192224BTL-899Btl20198—
+9K191685PicoWay Laser SystemCandela Corporation201920—
+9K182355Secret RF Smartcure Applicator with electrodesIlooda Co,., Ltd.20191—
+9K183392PicoLO Nd:YAG Picosecond Laser SystemLaseroptek Co., Ltd.20192—
+9K182997enlighten III Laser SystemCutera, Inc.20180—
+9K183307Magma Spark Pro (Magma Spark Plus, Alpha)Formatk Systems, Ltd.20180—
+9K181486DEKA Motus AYEl.En Electronic Engineering Spa20182—
+9K181272Picocare FamilyWontech Co., Ltd.20188—
+9K180654PINXEL-RF systemRohrer Aesthetics, LLC20183—
+9K173700PICOPLUS Laser SystemLutronic Corporation20187—
+9K180709truSculpt RF Device; truSculpt; truSculpt 3DCutera, Inc.20183—
+9K173582ThermiX Temperature Control Radiofrequency System, Accessories - RF ElectrodesThermigen, L.L.C20181—
+9K171262TempSureCynosure, Inc.201716—
+9K172004truSculptCutera, Inc.20173—
+9K170637sensiFirmEl Global Trade, Ltd.20173—
+9K162886Deka Motus AXEl.En Electronic Engineering Spa20171—
+9K171094Thermi Reusable Non-invasive RF ElectrodeThermgen, L.L.C20176—
+9K170936Cutera enlighten III Laser SystemCutera, Inc.201710—
+9K161632FAMILY OF SQUARE EPIL (Alex, Alex2, Nd:Yag, Alex+Nd:Yag)Bios S.R.L.20161—
+9K162781Magma SparkFormatk Systems, Ltd.20160—
+9K161043Profound SystemSyneron Candela Corporation20160—
+9K161403A.R.C. Laser Surgical Fibers and ProbesA.R.C Laser GmbH20160—
+9K161661Thermi RF AccessoriesThermi20163—
+9K161199EndyMed Contour HandpieceEndymed Medical, Ltd.20162—
+9K152731XP1100 RFBTL Industries, Inc.20160—
+9K153568InMode Plus SystemInmode MD, Ltd.201618—
+9K160368EVO platformQuanta System Spa201636—
+9K151793InMode RF SystemInmode MD, Ltd.20161—
+9K152012EVO platformQuanta System Spa201537—
+9K151473NaturaLase PiQo4 - NaturaLase Nd:Y AG 1064 Q-switched Laser with 532 nm accessory and…Focus Medical, LLC201537—
+9K150907Ellipse Nordlys/Ellipse Nordlys+, Ellipse Sirius, Ellipse Infinity, Ellipse Mjolner…Ellipse A/S20155—
+10K260945Ultima System (UL-800);Ultimate Face Package (UL-800-Face-Set);Ultimate Shape Extension…Fit-Pro KFT (Ltd.) - DBA E-Fit20260—
+10K261570Picosure WorkstationCynosure, LLC20260—
+10K260138LUNE PureHygieneEnamel Pure20260—
+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—
+10K252745Halo Sterile Single-use Radial Fiber…Micro-Energy Medical Technology Co., Ltd.20251—
+10K253007Laser 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—
+10K252345Picosecond Laser Device (PF131-BI)Risu Medical Technology Co., Ltd.20250—
+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—
+10K243630Medical Laser System Incanto / Evoline Platinum /EvolineSolar LS Cjsc20250—
+10K250113neoLaser Laser Surgery FibersG.N.S Neolaser, 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—
+10K231790The InMode System with the Morpheus8 ApplicatorsInMode, Ltd.202310—
+10K222790F65 Laser SystemLumenis Be, Ltd.20233—
+10K230373HELIOS 785 PicoLaseroptek Co., Ltd.20232—