510(k) Report

Devices descending from K000072

697 later devices reach Dornier Medilas D Skinpulse through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+8K243139Reverso Pro SystemIndiba S. A. U.20250—
+8K242532BTL-785BNF-EBTL Industries, Inc.20241—
+8K240897CellinewVIOL Co., Ltd.20240—
+8K242183Fractional CO2 Laser Therapy System (EXFU CO2)Weifang Mingliang Electronics Co., Ltd.20240—
+8K241951Lasya-TrinityBLUECORE COMPANY Co., Ltd.20240—
+8K242206ActivoDaeju Meditech Engineering Co., Ltd.20240—
+8K233473Deka LotusEl.En S.P.A.20241—
+8K222958mJOULE RF System and AccessoriesSciton, Inc20240—
+8K233757TitanPico Laser Workstation (PICO-450)Rhein Laser Technologies Co., Ltd.20240—
+8K240313Oligio XWontech Co., Ltd.20241—
+8K231896Diode Laser Therapy SystemBeijing Adss Development Co., Ltd.20240—
+8K233090DEKA AGAIN PRO familyEl.En S.P.A.20232—
+8K231495The Evolve System with the Transform ApplicatorInMode, Ltd.20231—
+8K231092T-Shape 2B&M S.R.L. Marketing Nel Benessere20230—
+8K232192Venus Versa PRO SystemVenus Concept, Inc.20230—
+8K221574LUDWIG Electrosurgical DeviceAesthetics Biomedical20220—
+8K213120OW100S (model OW100S-US)Tissue Regeneration Technologies, LLC Dba AS Softwave Trt20220—
+8K212663Helios IV 785Laseroptek Co., Ltd.20223—
+8K210084SilkroHironic Co., Ltd.20223—
+8K220592Venus BlissMAXVenus Concept USA, Inc.20221—
+8K220124YandR System, VoluDerm Handpiece, VoluDerm TipsPollogen, Ltd.20220—
+8K202848S2 Pigment Removal SystemLightsense Technologies, Ltd.20210—
+8K212107ReversoIntelis Instruments, Ltd.20211—
+8K203441The Alma Hybrid Laser SystemAlma Lasers, Ltd.20215—
+8K210226PicoSure WorkstationCynosure, LLC20213—
+8K203665STOP U Model UXV DevicePollogen, Ltd.20214—
+8K201685PotenzaJeisys Medical, Inc.20219—
+8K201735PlaDuo SystemShenB Co., Ltd.20203—
+8K200947InMode System with the Morhpeus8 ApplicatorsInMode, Ltd.202015—
+8K192350Medical Non-Ablative Fractional Laser SystemsWingderm Electro-Optics, Ltd.202021
+8K193426Elite iQCynosure, LLC20201—
+8K192583PicoLazer Laser SystemRohrer Aesthetics, LLC20200—
+8K193500Stellar M22 for Intense Pulsed Light (IPL) and Laser SystemLumenis, Ltd.202012—
+8K192224BTL-899Btl20198—
+8K191685PicoWay Laser SystemCandela Corporation201920—
+8K182355Secret RF Smartcure Applicator with electrodesIlooda Co,., Ltd.20191—
+8K183392PicoLO Nd:YAG Picosecond Laser SystemLaseroptek Co., Ltd.20192—
+8K182997enlighten III Laser SystemCutera, Inc.20180—
+8K183307Magma Spark Pro (Magma Spark Plus, Alpha)Formatk Systems, Ltd.20180—
+8K181486DEKA Motus AYEl.En Electronic Engineering Spa20182—
+8K181272Picocare FamilyWontech Co., Ltd.20188—
+8K180654PINXEL-RF systemRohrer Aesthetics, LLC20183—
+8K173700PICOPLUS Laser SystemLutronic Corporation20187—
+8K180709truSculpt RF Device; truSculpt; truSculpt 3DCutera, Inc.20183—
+8K173582ThermiX Temperature Control Radiofrequency System, Accessories - RF ElectrodesThermigen, L.L.C20181—
+8K171262TempSureCynosure, Inc.201716—
+8K172004truSculptCutera, Inc.20173—
+8K170637sensiFirmEl Global Trade, Ltd.20173—
+8K162886Deka Motus AXEl.En Electronic Engineering Spa20171—
+8K171094Thermi Reusable Non-invasive RF ElectrodeThermgen, L.L.C20176—
+8K170936Cutera enlighten III Laser SystemCutera, Inc.201710—
+8K161632FAMILY OF SQUARE EPIL (Alex, Alex2, Nd:Yag, Alex+Nd:Yag)Bios S.R.L.20161—
+8K162781Magma SparkFormatk Systems, Ltd.20160—
+8K161043Profound SystemSyneron Candela Corporation20160—
+8K161661Thermi RF AccessoriesThermi20163—
+8K161199EndyMed Contour HandpieceEndymed Medical, Ltd.20162—
+8K152731XP1100 RFBTL Industries, Inc.20160—
+8K153568InMode Plus SystemInmode MD, Ltd.201618—
+8K160368EVO platformQuanta System Spa201636—
+8K151793InMode RF SystemInmode MD, Ltd.20161—
+8K152012EVO platformQuanta System Spa201537—
+8K151473NaturaLase PiQo4 - NaturaLase Nd:Y AG 1064 Q-switched Laser with 532 nm accessory and…Focus Medical, LLC201537—
+8K150907Ellipse Nordlys/Ellipse Nordlys+, Ellipse Sirius, Ellipse Infinity, Ellipse Mjolner…Ellipse A/S20155—
+9K260945Ultima System (UL-800);Ultimate Face Package (UL-800-Face-Set);Ultimate Shape Extension…Fit-Pro KFT (Ltd.) - DBA E-Fit20260—
+9K261701Hemolase 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—
+9K261570Picosure WorkstationCynosure, LLC20260—
+9K253965CureLight Medical Diode Laser Systems (CureLight F2-A15; CureLight F2-B15; CureLight…Wuhan PHOMED Technology Company, Ltd.20260—
+9K251981Boston PICO (Boston PICO)Boston Aesthetics, Inc.20260—
+9K254290ZenTite (Unicorn+); ZenTite (Unicorn+I); ZenTite (Unicorn+II); ZenTite (Unicorn+III)Shenzhen Peninsula Medical Group20260—
+9K252369Boston Pico755Boston Aesthetics, Inc.20260—
+9K252345Picosecond Laser Device (PF131-BI)Risu Medical Technology Co., Ltd.20250—
+9K243123IPL Treatment Device (MDSQMC-01)Medusa (Guangxi)Medical Devices Co., Ltd.20250—
+9K251230The Alma Hybrid Laser SystemAlma Lasers, Inc.20250—
+9K243176BLESSING SystemCellah Medical Co., Ltd.20251—
+9K250809Stellar M22Lumenis Be, Ltd.20250—
+9K243630Medical Laser System Incanto / Evoline Platinum /EvolineSolar LS Cjsc20250—
+9K243957PicoalexWontech Co., Ltd.20250—
+9K250281Deka LotusEl.En S.P.A.20250—
+9K250200InbellaBody SystemInbella Medical, Inc.20250—
+9K243929Oligio XWontech Co., Ltd.20250—
+9K242534HandPICO Fractional Laser Handpiece TipVydence Medical20241—
+9K231216PotenzaJeisys Medical, Inc.20244—
+9K231287PotenzaJeisys Medical, Inc.20241—
+9K241092Youlaser PRIME; Youlaser PRIME CO2; Youlaser PRIME MTQuanta System Spa20240—
+9K233123SilkroHironic Co., Ltd.20241—
+9K241407Splendor X (Alex, Alex2, Nd:YAG, Alex+Nd:YAG)Bios S.R.L.20240—
+9K233120CWM-930S, Fixer DV9Chungwoo Co., Ltd.20240—
+9K233099GladiatorRohrer Aesthetics, LLC20240—
+9K240386Picosecond Nd:YAG Laser Systems (BL-C10)Shanghai Bele Medical Technology Co.,Ltd20240—
+9K240999Legend X Applicator VOPollogen, Ltd.20241—
+9K240396Elite iQ PRO (M122K1)Cynosure, LLC20240—
+9K230837PlazMagikAgnes Medical Co., Ltd.20240—
+9K233143PiXel8-RevealRohrer Aesthetics20240—
+9K233147PiXel8-RFRohrer Aesthetics20230—
+9K232223PlaDuo SystemShenB Co., Ltd.20230—
+9K231790The InMode System with the Morpheus8 ApplicatorsInMode, Ltd.202310—
+9K222790F65 Laser SystemLumenis Be, Ltd.20233—
+9K230373HELIOS 785 PicoLaseroptek Co., Ltd.20232—
+9K220322Pollogen STOP U Model UXV DevicePollogen, Ltd.20233—
+9K222260Capenergy C Equipment RF System - C25, C50, C100, C200, C300, C400, C500Capenergy Medical S.L.20233—