510(k) Report

Devices descending from K954031

751 later devices reach Compu-Blend Epilator through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+10K252345Picosecond Laser Device (PF131-BI)Risu Medical Technology Co., Ltd.20250—
+10K250731MateLaser Medical Diode Laser Systems (ML-DLS-30)Matelaser, Inc.20250—
+10K252272ORA Method LED Gua Sha (GS-04)Shenzhen Kaiyan Medical Equipment Co., Ltd.20250—
+10K251781Kala Mini 2.0 (Kala-04)Shenzhen Kaiyan Medical Equipment Co., Ltd.20250—
+10K251727GLAM LED Facial Mask (TB-2386F)Touchbeauty Beauty & Health (Shenzhen) Co., Ltd.20250—
+10K251588LED Light Therapy Mask (FCM902, FCM905, FCM906, FCM908, 11-001-RBMASK, FCM910)Shenzhen Fittop Health Technology Co., Ltd.20252—
+10K251076Diode Laser Hair Removal Machine (models: T60A, T60B, T60C, T60D, T60E)Shenzhen Lifotronic Technology Co., Ltd.20250—
+10K250761KALA Therapy Wand (Model: KALA-03)Shenzhen Kaiyan Medical Equipment Co., Ltd.20251—
+10K243123IPL Treatment Device (MDSQMC-01)Medusa (Guangxi)Medical Devices Co., Ltd.20250—
+10K251230The Alma Hybrid Laser SystemAlma Lasers, Inc.20250—
+10K243176BLESSING SystemCellah Medical Co., Ltd.20251—
+10K243764Medical Diode Laser (UTU3-F7B,UTU3-F7W,UTU3-G7B,UTU3-G7W,UTU-G20B,UTU-G20W)Wuhan Pioon Technology Co., Ltd.20250—
+10K251094Alma VeilWontech Co., Ltd.20250—
+10K250809Stellar M22Lumenis Be, Ltd.20250—
+10K242151Radiant Renewal Skincare Wand (HD-44,HD-44A ,HD-44B,HD-44C, HD-69, HD-69A, HD-69B)Shenzhen Nuon Medical Equipment Co., Ltd.20251—
+10K243630Medical Laser System Incanto / Evoline Platinum /EvolineSolar LS Cjsc20250—
+10K243957PicoalexWontech Co., Ltd.20250—
+10K241947EnergyLounger (TY-01)Shenzhen Kaiyan Medical Equipment Co., Ltd.20251—
+10K250281Deka LotusEl.En S.P.A.20250—
+10K241643WONTECH Surgical Optic Fibers (BA400/BA400R/BA600/BA600R)Wontech Co., Ltd.20252—
+10K242977308nm Excimer Phototherapy Device (CN-308E, KN-4003B3, KN-4003B4, KN-5000C KN-5000D…Xuzhou Kernel Medical Equipment Co., Ltd.20250—
+10K243147LGO-Surgical Laser FibersLight Guide Optics International, Ltd.20241—
+10K242534HandPICO Fractional Laser Handpiece TipVydence Medical20241—
+10K241670Fractional CO2 Laser Therapy System (FG900-S); Fractional CO2 Laser Therapy System…Beijing Adss Development Co., Ltd.20241—
+10K231216PotenzaJeisys Medical, Inc.20244—
+10K231287PotenzaJeisys Medical, Inc.20241—
+10K241092Youlaser PRIME; Youlaser PRIME CO2; Youlaser PRIME MTQuanta System Spa20240—
+10K241951Lasya-TrinityBLUECORE COMPANY Co., Ltd.20240—
+10K242202LightWalker Laser System FamilyFotona D.O.O.20241—
+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—
+10K2406581060nm laser body slimming machineHebei JT Medical Co., Ltd.20240—
+10K240999Legend X Applicator VOPollogen, Ltd.20241—
+10K234085LUNE™ PureHygieneEnamel Pure20241—
+10K240396Elite iQ PRO (M122K1)Cynosure, LLC20240—
+10K230047Medical Diode Laser SystemsGigaalaser Company, Ltd.20242—
+10K230837PlazMagikAgnes Medical Co., Ltd.20240—
+10K231896Diode Laser Therapy SystemBeijing Adss Development Co., Ltd.20240—
+10K233143PiXel8-RevealRohrer Aesthetics20240—
+10K232769BeaMed Laser Surgery FibersBt Beamedical Tachnoogies Ltd. (Beamed)20231—
+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—
+10K220322Pollogen STOP U Model UXV DevicePollogen, Ltd.20233—
+10K230819OmniGuide RFID Surgical Laser FibersOmni-Guide Holdings, Inc.20230—
+10K222260Capenergy C Equipment RF System - C25, C50, C100, C200, C300, C400, C500Capenergy Medical S.L.20233—
+10K222709Retraction, CWM-910T, APOLEX TiteChungwoo Co., Ltd.20230—
+10K222226EONDominion Aesthetic Technologies, Inc.20230—
+10K222221Deka HelixEl.En Electronic Engineering Spa20231—
+10K220853PicoWay Laser SystemCandela Corporation20221—
+10K221770Fiber Laser Treatment SystemShanghai Apolo Medical Technology Co., Ltd.20221—
+10K221427V-LaserWontech Co., Ltd.20222—
+10K212472AgeJetTriworks Group Srl20220—
+10K211000AcutronIlooda Co,., Ltd.20220—
+10K220793InnoVoyce Laser FiberInnovoyce, LLC20220—
+10K212127PicocaremajestyWontech Co., Ltd.20226—
+10K213344BTL-899ABTL Industries, Inc.20222—
+10K210350Gemini 2 810+980 Soft Tissue LaserAzena Medical, LLC20211—
+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—
+10K201387Ultrafast, Ultrafast Plus, Ultrafast LiteDentlight, Inc.20210—
+10K192970SlimusHironic Co., Ltd.20200—
+10K200116PicoSecond Nd: YAG Laser SystemShanghai Apolo Medical Technology Co., Ltd.20206—
+10K190678TempSureCynosure, Inc.201914—
+10K191162EpiLaze Multi-wavelength LaserRohrer Aesthetics, LLC20190—
+10K182365TempSure SystemCynosure, Inc.201815—
+10K173677InMode VLazeInmode MD, Ltd.20183—
+10K172771Epic Pro 940Biolase, Inc.20171—
+10K171992SculpSureCynosure, Inc.20178—
+10K171711Thunder, Thunder VT, Thunder HRQuanta System Spa20170—
+10K170116Thermi Injectable RF ElectrodesThermi20172—
+10K163190InMode RF SystemInmode MD, Ltd.20160—
+10K163222Discovery Pico FamilyQuanta System Spa201630—
+10K161162Frax 1550 for Ellipse Nordlys/ Ellipse Nordlys+, Ellipse Sirius, Ellipse Infinity…Ellipse A/S20164—
+10K161403A.R.C. Laser Surgical Fibers and ProbesA.R.C Laser GmbH20160—
+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—
+11K260138LUNE PureHygieneEnamel Pure20260—
+11K261214Pico Shining (Pico-K; Picofy)Speclipse, Inc.20260—
+11K260017Picosecond Nd:YAG Laser Systems (Model: HS-298)Shanghai Apolo Medical Technology Co., Ltd.20260—
+11K260765Gemini NOVA 810+980 Soft Tissue LaserAzena Medical, LLC20260—
+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—
+11K251254Ignite RF SystemInMode, Ltd.20260—
+11K250341Sensilift Pro (ST300XXYYZZZ)El Global Trade, Ltd.20260—
+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—
+11K252367InbellaMulti SystemInbella Medical, Inc.20250—
+11K252447Picosecond laser device (BMPS4)Hebei Newangie Technology Co., Ltd.20250—