510(k) Report

Devices descending from K971341

978 later devices reach Kirwan Model 28 1000 Bipolar Coagulator through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+10K170936Cutera enlighten III Laser SystemCutera, Inc.201710—
+10K161632FAMILY OF SQUARE EPIL (Alex, Alex2, Nd:Yag, Alex+Nd:Yag)Bios S.R.L.20161—
+10K162781Magma SparkFormatk Systems, Ltd.20160—
+10K161043Profound SystemSyneron Candela Corporation20160—
+10K161403A.R.C. Laser Surgical Fibers and ProbesA.R.C Laser GmbH20160—
+10K161661Thermi RF AccessoriesThermi20163—
+10K161199EndyMed Contour HandpieceEndymed Medical, Ltd.20162—
+10K152731XP1100 RFBTL Industries, Inc.20160—
+10K153568InMode Plus SystemInmode MD, Ltd.201618—
+10K160368EVO platformQuanta System Spa201636—
+10K151793InMode RF SystemInmode MD, Ltd.20161—
+10K152012EVO platformQuanta System Spa201537—
+10K151473NaturaLase PiQo4 - NaturaLase Nd:Y AG 1064 Q-switched Laser with 532 nm accessory and…Focus Medical, LLC201537—
+10K150907Ellipse Nordlys/Ellipse Nordlys+, Ellipse Sirius, Ellipse Infinity, Ellipse Mjolner…Ellipse A/S20155—
+11K261602Eye Recovery Pro (PH-e03)Shenzhen Goodwind Technology Development Co., Ltd.20260—
+11K261601LED Light Therapy Mask (M01, M02, M03, M05, M06, M07, M08)Shenzhen Chuangtong Yigou Technology Co., Ltd.20260—
+11K261407XPREEN LED Light Therapy Masks (XPRE322, XPRE326, XPRE327, XPRE342, XPRE368, XPRE422…Dongguan Miqiang Technology Co., Ltd.20260—
+11K261052LED Light Therapy Masks (LED Face Mask Pro FAC08NA, LED Chest Mask Pro FAC09NA)Guangdong Newdermo Biotech Co., Ltd.20260—
+11K260946LED Light Therapy Mask (K9C-TK, K9C-K, K9P-YK, K9P-K, FM-03BK, FM-09K)Guangdong Newdermo Biotech Co., Ltd.20260—
+11K261570Picosure WorkstationCynosure, LLC20260—
+11K260138LUNE PureHygieneEnamel Pure20260—
+11K254079LED Light Therapy Mask (Models: T2, RLD10)Shenzhen Desida Technology Co., Ltd.20260—
+11K251981Boston PICO (Boston PICO)Boston Aesthetics, Inc.20260—
+11K254290ZenTite (Unicorn+); ZenTite (Unicorn+I); ZenTite (Unicorn+II); ZenTite (Unicorn+III)Shenzhen Peninsula Medical Group20260—
+11K252369Boston Pico755Boston Aesthetics, Inc.20260—
+11K253086LED Light Therapy Device (Models: SG-FM, SG-FE)Sunglor Technology Co., Ltd.20250—
+11K252745Halo Sterile Single-use Radial Fiber…Micro-Energy Medical Technology Co., Ltd.20251—
+11K253007Laser 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—
+11K252308LED Beauty Mask (RLBXX)Atop Lighting Co., Ltd.20250—
+11K252345Picosecond Laser Device (PF131-BI)Risu Medical Technology Co., Ltd.20250—
+11K252264MEGELIN LED Light Therapy Mask (JML1, JML1+JML2); MEGELIN LED Light Therapy Mask (JML3…Shenzhen Zhenxing Ruitong Technology Co., Ltd.20252—
+11K252093Light Therapy Mask (1019055)Merchsource, LLC20250—
+11K243123IPL Treatment Device (MDSQMC-01)Medusa (Guangxi)Medical Devices Co., Ltd.20250—
+11K250581KALA Red Light Face Mask (KALA-01)Shenzhen Kaiyan Medical Equipment Co., Ltd.20250—
+11K251230The Alma Hybrid Laser SystemAlma Lasers, Inc.20250—
+11K242755Medical Diode Laser Systems (VELAS II-30B, VELAS II-30A, GBOX-15AB, GBOX-20B, CHEESE…Gigaalaser Company, Ltd.20251—
+11K243176BLESSING SystemCellah Medical Co., Ltd.20251—
+11K250809Stellar M22Lumenis Be, Ltd.20250—
+11K243630Medical Laser System Incanto / Evoline Platinum /EvolineSolar LS Cjsc20250—
+11K250113neoLaser Laser Surgery FibersG.N.S Neolaser, Ltd.20250—
+11K243957PicoalexWontech Co., Ltd.20250—
+11K250281Deka LotusEl.En S.P.A.20250—
+11K250200InbellaBody SystemInbella Medical, Inc.20250—
+11K242941CO2 Laser Therapy Systems (SHE-LSP003-1)Beijing Sano Laser S&T Development Co.,Ltd20250—
+11K243929Oligio XWontech Co., Ltd.20250—
+11K242534HandPICO Fractional Laser Handpiece TipVydence Medical20241—
+11K231216PotenzaJeisys Medical, Inc.20244—
+11K242382décoLITE LED DeviceiSMART Developments, Ltd.20246—
+11K231287PotenzaJeisys Medical, Inc.20241—
+11K241092Youlaser PRIME; Youlaser PRIME CO2; Youlaser PRIME MTQuanta System Spa20240—
+11K233123SilkroHironic Co., Ltd.20241—
+11K241407Splendor X (Alex, Alex2, Nd:YAG, Alex+Nd:YAG)Bios S.R.L.20240—
+11K233120CWM-930S, Fixer DV9Chungwoo Co., Ltd.20240—
+11K233099GladiatorRohrer Aesthetics, LLC20240—
+11K240386Picosecond Nd:YAG Laser Systems (BL-C10)Shanghai Bele Medical Technology Co.,Ltd20240—
+11K240999Legend X Applicator VOPollogen, Ltd.20241—
+11K240396Elite iQ PRO (M122K1)Cynosure, LLC20240—
+11K230837PlazMagikAgnes Medical Co., Ltd.20240—
+11K233143PiXel8-RevealRohrer Aesthetics20240—
+11K233147PiXel8-RFRohrer Aesthetics20230—
+11K232223PlaDuo SystemShenB Co., Ltd.20230—
+11K231790The InMode System with the Morpheus8 ApplicatorsInMode, Ltd.202310—
+11K222790F65 Laser SystemLumenis Be, Ltd.20233—
+11K230373HELIOS 785 PicoLaseroptek Co., Ltd.20232—
+11K230351LED Facial MaskShenzhen Sungpo Hi-Tech Electronic Co., Ltd.202333—
+11K220322Pollogen STOP U Model UXV DevicePollogen, Ltd.20233—
+11K222260Capenergy C Equipment RF System - C25, C50, C100, C200, C300, C400, C500Capenergy Medical S.L.20233—
+11K222709Retraction, CWM-910T, APOLEX TiteChungwoo Co., Ltd.20230—
+11K222221Deka HelixEl.En Electronic Engineering Spa20231—
+11K221775LED Light Therapy Mask (model: MK-78, MK-04, MK66-H, MK66R-B, EL00003)Light Tree Ventures Europe B.V.20227—
+11K221946LED Light Therapy Mask (model: MK66R-B)Light Tree Ventures Europe B.V.202218—
+11K220853PicoWay Laser SystemCandela Corporation20221—
+11K221770Fiber Laser Treatment SystemShanghai Apolo Medical Technology Co., Ltd.20221—
+11K214015Palm NRG cellulite body device (model: Palm NRG body device)Heat IN A Click, LLC20220—
+11K221151Beauty LED Mask, Model: KFB265Hunan Guangye Biotechnology Co., Ltd.202241—
+11K221407truSculpt iDCutera, Inc.20222—
+11K212472AgeJetTriworks Group Srl20220—
+11K211000AcutronIlooda Co,., Ltd.20220—
+11K212127PicocaremajestyWontech Co., Ltd.20226—
+11K213184MZ Skin LightMAX Supercharged LED Mask 2.0Mz Skin202135—
+11K201773PicohiHironic Co., Ltd.20215—
+11K211821DEKA Motus AZEl.En Electronic Engineering Spa20211—
+11K202884SR-1 Skin Treatment SystemAVAVA, Inc.20214—
+11K203491PicoLO Nd: YAG Picosecond Laser SystemLaseroptek Co., Ltd.20211—
+11K202199BTL-899STBtl20216—
+11K200116PicoSecond Nd: YAG Laser SystemShanghai Apolo Medical Technology Co., Ltd.20206—
+11K191855EmFace DeviceInmode MD, Ltd.20191—
+11K190678TempSureCynosure, Inc.201914—
+11K182365TempSure SystemCynosure, Inc.201815—
+11K181095RF-ReliefEl Global Trade, Ltd.20181—
+11K173677InMode VLazeInmode MD, Ltd.20183—
+11K172302InMode PLUS SystemInmode MD, Ltd.201713—
+11K171711Thunder, Thunder VT, Thunder HRQuanta System Spa20170—
+11K170116Thermi Injectable RF ElectrodesThermi20172—
+11K163190InMode RF SystemInmode MD, Ltd.20160—
+11K163222Discovery Pico FamilyQuanta System Spa201630—
+11K161162Frax 1550 for Ellipse Nordlys/ Ellipse Nordlys+, Ellipse Sirius, Ellipse Infinity…Ellipse A/S20164—
+12K254185Potenza PrimeJeisys Medical Incorporated20260—
+12K2618211565nm Laser Therapy Device (PZ-JG86-01,PZ-JG86-02)Zhengzhou PZ Laser Slim Technology Co., Ltd.20260—
+12K253859Scarlet Pro (Scarlet Pro)VIOL Co., Ltd.20260—