510(k) Report

Devices descending from K950493

1,051 later devices reach Photoderm VL. through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+9K250041Medical Picosecond ND: YAG Laser System (PZ-6)Zhengzhou PZ Laser Slim Technology Co., Ltd.20250—
+9K243764Medical Diode Laser (UTU3-F7B,UTU3-F7W,UTU3-G7B,UTU3-G7W,UTU-G20B,UTU-G20W)Wuhan Pioon Technology Co., Ltd.20250—
+9K241643WONTECH Surgical Optic Fibers (BA400/BA400R/BA600/BA600R)Wontech Co., Ltd.20252—
+9K243139Reverso Pro SystemIndiba S. A. U.20250—
+9K233118DUET-V (Model: ESK-3261DV)Eunsung Global Corp20250—
+9K243147LGO-Surgical Laser FibersLight Guide Optics International, Ltd.20241—
+9K241670Fractional CO2 Laser Therapy System (FG900-S); Fractional CO2 Laser Therapy System…Beijing Adss Development Co., Ltd.20241—
+9K242598DEFINE System (AG612444A)InMode, Ltd.20240—
+9K242382décoLITE LED DeviceiSMART Developments, Ltd.20246—
+9K242183Fractional CO2 Laser Therapy System (EXFU CO2)Weifang Mingliang Electronics Co., Ltd.20240—
+9K241144Picosecond Nd:YAG Laser (PICOCAREMAJESTY)Wontech Co., Ltd.20241—
+9K241459MOTUS PRO FamilyEl.En S.P.A.20240—
+9K240017InMode System with the Morpheus8 90 ApplicatorInMode, Ltd.20240—
+9K233007Picosecond Nd:YAG Laser System; PICO LEGENDAmi, Inc.20241—
+9K240118Picosecond Nd:YAG Laser SystemSmedtrum Medical Technology Co., Ltd.20240—
+9K234085LUNE™ PureHygieneEnamel Pure20241—
+9K234104PICOANDY (Q-Switched Nd:YAG Laser)Wontech Co., Ltd.20242—
+9K230047Medical Diode Laser SystemsGigaalaser Company, Ltd.20242—
+9K233018PICOSECOND Nd:YAG Laser SystemIds, Ltd.20232—
+9K232769BeaMed Laser Surgery FibersBt Beamedical Tachnoogies Ltd. (Beamed)20231—
+9K232532Nd:Yag Laser Therapy SystemsBeijing Unt Technology Co., Ltd.20230—
+9K223033Tixel® 2 SystemNovoxel, Ltd.20230—
+9K230351LED Facial MaskShenzhen Sungpo Hi-Tech Electronic Co., Ltd.202333—
+9K230819OmniGuide RFID Surgical Laser FibersOmni-Guide Holdings, Inc.20230—
+9K221775LED Light Therapy Mask (model: MK-78, MK-04, MK66-H, MK66R-B, EL00003)Light Tree Ventures Europe B.V.20227—
+9K221946LED Light Therapy Mask (model: MK66R-B)Light Tree Ventures Europe B.V.202218—
+9K213674CellFX SystemPulse Biosciences, Inc.20220—
+9K222075CellFX SystemPulse Biosciences, Inc.20220—
+9K220268Picosecond Laser System (Model PS10-A and PS10-B)Beijing Adss Development Co., Ltd.20221—
+9K221671CellFX® SystemPulse Biosciences, Inc.20220—
+9K221151Beauty LED Mask, Model: KFB265Hunan Guangye Biotechnology Co., Ltd.202241—
+9K210084SilkroHironic Co., Ltd.20223—
+9K220793InnoVoyce Laser FiberInnovoyce, LLC20220—
+9K213889PicoStarAsclepion Laser Technologies GmbH20220—
+9K211639BTL-785WBTL Industries, Inc.20227—
+9K212573PicoLO PremiumLaseroptek Co., Ltd.20210—
+9K213184MZ Skin LightMAX Supercharged LED Mask 2.0Mz Skin202135—
+9K210350Gemini 2 810+980 Soft Tissue LaserAzena Medical, LLC20211—
+9K212107ReversoIntelis Instruments, Ltd.20211—
+9K201387Ultrafast, Ultrafast Plus, Ultrafast LiteDentlight, Inc.20210—
+9K192545PotenzaJeisys Medical Incorporated202020—
+9K192695InMode System with the Morpheus8 (Fractora) ApplicatorsInmode MD, Ltd.201916—
+9K191842Discovery Pico, Discovery Pico Plus, Discovery Pico DermQuanta System Spa201918—
+9K182355Secret RF Smartcure Applicator with electrodesIlooda Co,., Ltd.20191—
+9K183450EmBody SystemInmode MD, Ltd.20198—
+9K180654PINXEL-RF systemRohrer Aesthetics, LLC20183—
+9K173359Fractional CO2 Surgical Laser SystemAmi, Inc.20180—
+9K173503Pollogen Legend SystemPollogen, Ltd.20183—
+9K172771Epic Pro 940Biolase, Inc.20171—
+9K161403A.R.C. Laser Surgical Fibers and ProbesA.R.C Laser GmbH20160—
+9K151179ZELTIQ CoolSculpting SystemZeltiq Aesthetics, Inc.201526—
+9K142491ZEL TIQ CoolSculpting SystemZeltiq Aesthetics, Inc.201527—
+9K133212Zeltiq Coolsculpting SystemZeltiq Aesthetics, Inc.201430—
+10K2615891927nm Thulium Laser System (PZ-DJG85-01, PZ-DJG85-02)Zhengzhou PZ Laser Slim Technology Co., Ltd.20260—
+10K261851LED Light Therapy Mask (JML1, JML1+JML2); LED Light Therapy Mask (JML3, JML3+JML4); LED…Shenzhen Qianyu Technology Co., Ltd.20260—
+10K260138LUNE PureHygieneEnamel Pure20260—
+10K260765Gemini NOVA 810+980 Soft Tissue LaserAzena Medical, LLC20260—
+10K251988Boston iFace (Boston iFace)Boston 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—
+10K252096Light Therapy Decollete Mask (1019135)Merchsource, LLC20250—
+10K250966CurrentBody Skin™ LED Light Therapy Mask Series 2 (MK-90H)Shenzhen Kaiyan Medical Equipment Co., Ltd.20250—
+10K242755Medical Diode Laser Systems (VELAS II-30B, VELAS II-30A, GBOX-15AB, GBOX-20B, CHEESE…Gigaalaser Company, Ltd.20251—
+10K242068LED Light Therapy Mask (RT01)Ningbo Dechang Electrical Machinery Made Co.,Ltd20250—
+10K250113neoLaser Laser Surgery FibersG.N.S Neolaser, Ltd.20250—
+10K241832Unicorn+ RF System (Unicorn+); Unicorn+ RF System (Unicorn+ I); Unicorn+ RF System…Boston Aesthetics, Inc.20251—
+10K242941CO2 Laser Therapy Systems (SHE-LSP003-1)Beijing Sano Laser S&T Development Co.,Ltd20250—
+10K243040LED Light Therapy Mask…Shenzhen Siken 3D Technology Development Co., Ltd.20241—
+10K240991eMVFit (MVF-10M)Weero Co., Ltd.20240—
+10K233123SilkroHironic Co., Ltd.20241—
+10K233120CWM-930S, Fixer DV9Chungwoo Co., Ltd.20240—
+10K233099GladiatorRohrer Aesthetics, LLC20240—
+10K222958mJOULE RF System and AccessoriesSciton, Inc20240—
+10K233114LED silicone mask (Model: LP-RVTGLWP-WHT, LP-RVTGLW-WHT, TLM200)Shenzhen Idea Light Limited20241—
+10K233147PiXel8-RFRohrer Aesthetics20230—
+10K222556BTL-785XBTL Industries, Inc.20235—
+10K221574LUDWIG Electrosurgical DeviceAesthetics Biomedical20220—
+10K211000AcutronIlooda Co,., Ltd.20220—
+10K214103Shani Darden LED light therapy maskHarpar Grace International202219—
+10K220124YandR System, VoluDerm Handpiece, VoluDerm TipsPollogen, Ltd.20220—
+10K210877Evolve System with the T3 ApplicatorInMode, Ltd.20215—
+10K201285InMode Evolve System with the Tone ApplicatorInMode, Ltd.20216—
+10K201685PotenzaJeisys Medical, Inc.20219—
+10K201735PlaDuo SystemShenB Co., Ltd.20203—
+10K202503ChromeQuanta System Spa202012—
+10K200947InMode System with the Morhpeus8 ApplicatorsInMode, Ltd.202015—
+10K160470SculpSureCynosure, Inc.201620—
+10K160259ZELTIQ CoolSculpting SystemZeltiq Aesthetics, Inc.201615—
+10K150724SculpSureCynosure, Inc.201521—
+10K150230SculpSureCynosure, Inc.201521—
+11K261701Hemolase 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—
+11K253542Apollo Quattro (APQ-10M)Weero Co., Ltd.20260—
+11K253965CureLight Medical Diode Laser Systems (CureLight F2-A15; CureLight F2-B15; CureLight…Wuhan PHOMED Technology Company, Ltd.20260—
+11K254290ZenTite (Unicorn+); ZenTite (Unicorn+I); ZenTite (Unicorn+II); ZenTite (Unicorn+III)Shenzhen Peninsula Medical Group20260—
+11K251334New Doublo 2.0Hironic Co., Ltd.20250—
+11K241433EVE Synergy (EVE-20M)Weero Co., Ltd.20251—
+11K243176BLESSING SystemCellah Medical Co., Ltd.20251—
+11K242688Finiff SystemSkingrab Co., Ltd.20240—
+11K231216PotenzaJeisys Medical, Inc.20244—
+11K231287PotenzaJeisys Medical, Inc.20241—