510(k) Report

Devices descending from K003993

705 later devices reach Dornier Medilas D Skinpulse Laser System (Skinpulse) through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+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—
+9K222709Retraction, CWM-910T, APOLEX TiteChungwoo Co., Ltd.20230—
+9K222221Deka HelixEl.En Electronic Engineering Spa20231—
+9K220853PicoWay Laser SystemCandela Corporation20221—
+9K221770Fiber Laser Treatment SystemShanghai Apolo Medical Technology Co., Ltd.20221—
+9K214015Palm NRG cellulite body device (model: Palm NRG body device)Heat IN A Click, LLC20220—
+9K221407truSculpt iDCutera, Inc.20222—
+9K212472AgeJetTriworks Group Srl20220—
+9K211000AcutronIlooda Co,., Ltd.20220—
+9K212127PicocaremajestyWontech Co., Ltd.20226—
+9K201773PicohiHironic Co., Ltd.20215—
+9K211821DEKA Motus AZEl.En Electronic Engineering Spa20211—
+9K202884SR-1 Skin Treatment SystemAVAVA, Inc.20214—
+9K203491PicoLO Nd: YAG Picosecond Laser SystemLaseroptek Co., Ltd.20211—
+9K202199BTL-899STBtl20216—
+9K200116PicoSecond Nd: YAG Laser SystemShanghai Apolo Medical Technology Co., Ltd.20206—
+9K191855EmFace DeviceInmode MD, Ltd.20191—
+9K190678TempSureCynosure, Inc.201914—
+9K182365TempSure SystemCynosure, Inc.201815—
+9K181095RF-ReliefEl Global Trade, Ltd.20181—
+9K173677InMode VLazeInmode MD, Ltd.20183—
+9K172302InMode PLUS SystemInmode MD, Ltd.201713—
+9K171711Thunder, Thunder VT, Thunder HRQuanta System Spa20170—
+9K170116Thermi Injectable RF ElectrodesThermi20172—
+9K163190InMode RF SystemInmode MD, Ltd.20160—
+9K163222Discovery Pico FamilyQuanta System Spa201630—
+9K161162Frax 1550 for Ellipse Nordlys/ Ellipse Nordlys+, Ellipse Sirius, Ellipse Infinity…Ellipse A/S20164—
+10K254185Potenza PrimeJeisys Medical Incorporated20260—
+10K2618211565nm Laser Therapy Device (PZ-JG86-01,PZ-JG86-02)Zhengzhou PZ Laser Slim Technology Co., Ltd.20260—
+10K253859Scarlet Pro (Scarlet Pro)VIOL Co., Ltd.20260—
+10K253484Lutronic GeniusCynosure Lutronic Technology Corporation20260—
+10K253803MILAN SystemLumenis Be, Ltd.20260—
+10K260017Picosecond Nd:YAG Laser Systems (Model: HS-298)Shanghai Apolo Medical Technology Co., Ltd.20260—
+10K253829Medical Ultra-Pico Laser Treatment System (CM-SP-1064&532)Beijing HuaCheng Taike Technology Co., Ltd.20260—
+10K251435InbellaIgnite RF SystemInbella Medical, Inc.20260—
+10K252753Vydence Family of LasersVydence Medical Industria E Commercio Ltda20260—
+10K251254Ignite RF SystemInMode, Ltd.20260—
+10K250341Sensilift Pro (ST300XXYYZZZ)El Global Trade, Ltd.20260—
+10K252367InbellaMulti SystemInbella Medical, Inc.20250—
+10K252447Picosecond laser device (BMPS4)Hebei Newangie Technology Co., Ltd.20250—
+10K251334New Doublo 2.0Hironic Co., Ltd.20250—
+10K250734OptiLUV DevicePollogen, Ltd.20250—
+10K251031Fiber Laser Treatment Systems (HS-232,HS-233)Shanghai Apolo Medical Technology Co., Ltd.20250—
+10K250041Medical Picosecond ND: YAG Laser System (PZ-6)Zhengzhou PZ Laser Slim Technology Co., Ltd.20250—
+10K242469RFMagik LiteAgnes Medical Co., Ltd.20252—
+10K242598DEFINE System (AG612444A)InMode, Ltd.20240—
+10K242349FoLixLumenis Be, Ltd.20240—
+10K241144Picosecond Nd:YAG Laser (PICOCAREMAJESTY)Wontech Co., Ltd.20241—
+10K241459MOTUS PRO FamilyEl.En S.P.A.20240—
+10K233007Picosecond Nd:YAG Laser System; PICO LEGENDAmi, Inc.20241—
+10K240752Deka ToroEl.En S.P.A.20240—
+10K233766Geneo X ElitePollogen, Ltd.20240—
+10K240118Picosecond Nd:YAG Laser SystemSmedtrum Medical Technology Co., Ltd.20240—
+10K233642InMode RF SystemInMode, Ltd.20244—
+10K234104PICOANDY (Q-Switched Nd:YAG Laser)Wontech Co., Ltd.20242—
+10K232424CurrentBody Skin RFEl Global Trade, Ltd.20240—
+10K233018PICOSECOND Nd:YAG Laser SystemIds, Ltd.20232—
+10K221268SR-1 Skin Treatment SystemAVAVA, Inc.20223—
+10K223110truSculpt iDCutera, Inc.20221—
+10K220268Picosecond Laser System (Model PS10-A and PS10-B)Beijing Adss Development Co., Ltd.20221—
+10K212573PicoLO PremiumLaseroptek Co., Ltd.20210—
+10K211107BTL-899 FPBTL Industries, Inc.20213—
+10K200241TempSure SystemCynosure, LLC202013—
+10K183450EmBody SystemInmode MD, Ltd.20198—
+10K180406Ellipse YdunEllipse A/S20180—
+10K171945Discovery Pico, Discovery Pico PlusQuanta System Spa201721—
+11K252888NeoSculpt PlusS&M Medical Co., Ltd.20260—
+11K250217AGNES UltraAgnes Medical Co., Ltd.20250—
+11K243713Single Use RF Surgical Electrode (Needle Type) (AN-B, AN-C, AN-E, AN-I, AN-S, AN-W3A…Agnes Medical Co., Ltd.20250—
+11K242553MIRARI® Cold Plasma System ( GV-M2-01)General Vibronics, Inc.20240—
+11K240991eMVFit (MVF-10M)Weero Co., Ltd.20240—
+11K240780InMode RF SystemInMode, Ltd.20243—
+11K223871Miria Skin Treatment SystemAVAVA, Inc.20232—
+11K212891TempSure SystemCynosure, LLC20221—
+11K213344BTL-899ABTL Industries, Inc.20222—
+11K210129RF Thermal SystemLuvo Medical Technologies, Inc.20211—
+11K210877Evolve System with the T3 ApplicatorInMode, Ltd.20215—
+11K201285InMode Evolve System with the Tone ApplicatorInMode, Ltd.20216—
+11K172376Discovery Pico, Discovery Pico PlusQuanta System Spa201720—
+12K253542Apollo Quattro (APQ-10M)Weero Co., Ltd.20260—
+12K241433EVE Synergy (EVE-20M)Weero Co., Ltd.20251—
+12K250402AVAVA™ Skin Treatment SystemAVAVA, Inc.20251—
+12K243737Inbella RF SystemInbella Medical, Inc.20250—
+12K240992eMVFit (MVF-10M)Weero Co., Ltd.20240—
+12K230467BTL-899FBTL Industries, Inc.20231—
+12K230167BACK 4Swims America Corp20230—
+12K230037BACK 3Swims America Corp20230—
+12K223292TempSure SystemCynosure, LLC20220—
+12K213889PicoStarAsclepion Laser Technologies GmbH20220—
+12K191842Discovery Pico, Discovery Pico Plus, Discovery Pico DermQuanta System Spa201918—
+13K252155AVAVA™ Skin Treatment SystemAVAVA, Inc.20250—
+13K202503ChromeQuanta System Spa202012—
+14K253765Vanish ProDdc Technologies, Inc.20260—