510(k) Report

Devices descending from K020453

1,018 later devices reach Palomar Estelux Pulsed Light System and Palomar Coolroller through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+9K242688Finiff SystemSkingrab Co., Ltd.20240—
+9K243040LED Light Therapy Mask…Shenzhen Siken 3D Technology Development Co., Ltd.20241—
+9K241670Fractional CO2 Laser Therapy System (FG900-S); Fractional CO2 Laser Therapy System…Beijing Adss Development Co., Ltd.20241—
+9K231216PotenzaJeisys Medical, Inc.20244—
+9K242598DEFINE System (AG612444A)InMode, Ltd.20240—
+9K231287PotenzaJeisys Medical, Inc.20241—
+9K241144Picosecond Nd:YAG Laser (PICOCAREMAJESTY)Wontech Co., Ltd.20241—
+9K233123SilkroHironic Co., Ltd.20241—
+9K241459MOTUS PRO FamilyEl.En S.P.A.20240—
+9K233007Picosecond Nd:YAG Laser System; PICO LEGENDAmi, Inc.20241—
+9K233120CWM-930S, Fixer DV9Chungwoo Co., Ltd.20240—
+9K233099GladiatorRohrer Aesthetics, LLC20240—
+9K240752Deka ToroEl.En S.P.A.20240—
+9K240999Legend X Applicator VOPollogen, Ltd.20241—
+9K240118Picosecond Nd:YAG Laser SystemSmedtrum Medical Technology Co., Ltd.20240—
+9K233849BTL-499BTL Industries, Inc.20240—
+9K233604BTL-785SBTL Industries, Inc.20243—
+9K234085LUNE™ PureHygieneEnamel Pure20241—
+9K234104PICOANDY (Q-Switched Nd:YAG Laser)Wontech Co., Ltd.20242—
+9K230047Medical Diode Laser SystemsGigaalaser Company, Ltd.20242—
+9K230837PlazMagikAgnes Medical Co., Ltd.20240—
+9K233143PiXel8-RevealRohrer Aesthetics20240—
+9K233114LED silicone mask (Model: LP-RVTGLWP-WHT, LP-RVTGLW-WHT, TLM200)Shenzhen Idea Light Limited20241—
+9K233018PICOSECOND Nd:YAG Laser SystemIds, Ltd.20232—
+9K232769BeaMed Laser Surgery FibersBt Beamedical Tachnoogies Ltd. (Beamed)20231—
+9K233147PiXel8-RFRohrer Aesthetics20230—
+9K232223PlaDuo SystemShenB Co., Ltd.20230—
+9K231790The InMode System with the Morpheus8 ApplicatorsInMode, Ltd.202310—
+9K222790F65 Laser SystemLumenis Be, Ltd.20233—
+9K230819OmniGuide RFID Surgical Laser FibersOmni-Guide Holdings, Inc.20230—
+9K222221Deka HelixEl.En Electronic Engineering Spa20231—
+9K221770Fiber Laser Treatment SystemShanghai Apolo Medical Technology Co., Ltd.20221—
+9K220268Picosecond Laser System (Model PS10-A and PS10-B)Beijing Adss Development Co., Ltd.20221—
+9K212472AgeJetTriworks Group Srl20220—
+9K211000AcutronIlooda Co,., Ltd.20220—
+9K220793InnoVoyce Laser FiberInnovoyce, LLC20220—
+9K214103Shani Darden LED light therapy maskHarpar Grace International202219—
+9K212573PicoLO PremiumLaseroptek Co., Ltd.20210—
+9K210350Gemini 2 810+980 Soft Tissue LaserAzena Medical, LLC20211—
+9K201387Ultrafast, Ultrafast Plus, Ultrafast LiteDentlight, Inc.20210—
+9K183450EmBody SystemInmode MD, Ltd.20198—
+9K172771Epic Pro 940Biolase, Inc.20171—
+9K171945Discovery Pico, Discovery Pico PlusQuanta System Spa201721—
+9K162781Magma SparkFormatk Systems, Ltd.20160—
+9K161403A.R.C. Laser Surgical Fibers and ProbesA.R.C Laser GmbH20160—
+9K160470SculpSureCynosure, Inc.201620—
+9K160259ZELTIQ CoolSculpting SystemZeltiq Aesthetics, Inc.201615—
+9K150724SculpSureCynosure, Inc.201521—
+9K150230SculpSureCynosure, Inc.201521—
+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—
+10K260138LUNE PureHygieneEnamel Pure20260—
+10K253750BTL-785NEHBTL Industries, Inc.20260—
+10K260765Gemini NOVA 810+980 Soft Tissue LaserAzena Medical, LLC20260—
+10K251435InbellaIgnite RF SystemInbella Medical, Inc.20260—
+10K251254Ignite RF SystemInMode, Ltd.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—
+10K252367InbellaMulti SystemInbella Medical, Inc.20250—
+10K251334New Doublo 2.0Hironic Co., Ltd.20250—
+10K242755Medical Diode Laser Systems (VELAS II-30B, VELAS II-30A, GBOX-15AB, GBOX-20B, CHEESE…Gigaalaser Company, Ltd.20251—
+10K242469RFMagik LiteAgnes Medical Co., Ltd.20252—
+10K250113neoLaser Laser Surgery FibersG.N.S Neolaser, Ltd.20250—
+10K242941CO2 Laser Therapy Systems (SHE-LSP003-1)Beijing Sano Laser S&T Development Co.,Ltd20250—
+10K242532BTL-785BNF-EBTL Industries, Inc.20241—
+10K240991eMVFit (MVF-10M)Weero Co., Ltd.20240—
+10K242349FoLixLumenis Be, Ltd.20240—
+10K233642InMode RF SystemInMode, Ltd.20244—
+10K230124LUSTRE ClearSkin Renew Pro Facewear Mask (Model: PR4001)Light Tree Ventures Europe B.V.202310—
+10K211681EONDominion Aesthetic Technologies, Inc.20221—
+10K210877Evolve System with the T3 ApplicatorInMode, Ltd.20215—
+10K201285InMode Evolve System with the Tone ApplicatorInMode, Ltd.20216—
+10K191068Powersculp laser lipolysis systemWuhan Lotuxs Technology Co., Ltd.20196—
+10K190743Venus BlissVenus Concept USA, Inc.20194—
+10K172376Discovery Pico, Discovery Pico PlusQuanta System Spa201720—
+10K171111SculpsureCynosure, Inc.201710—
+10K162050ZELTIQ CoolSculpting SystemZeltiq Aesthetics, Inc.201614—
+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—
+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—
+11K241433EVE Synergy (EVE-20M)Weero Co., Ltd.20251—
+11K240992eMVFit (MVF-10M)Weero Co., Ltd.20240—
+11K240780InMode RF SystemInMode, Ltd.20243—
+11K233962ReBorn (1050nm)Lightfective, Ltd.20240—
+11K230167BACK 4Swims America Corp20230—
+11K230037BACK 3Swims America Corp20230—
+11K222226EONDominion Aesthetic Technologies, Inc.20230—
+11K222265DiosculptShanghai Wonderful Opto-Electrics Tech.Co.,Ltd20220—
+11K213889PicoStarAsclepion Laser Technologies GmbH20220—
+11K213308Venus BlissMAXVenus Concept USA, Inc.20222—
+11K212331BodySculpRohrer Aesthetics, LLC20211—
+11K211402Powersculp laser lipolysis systemLotuxs Medtech (Suzhou) Co., Ltd.20210—
+11K192970SlimusHironic Co., Ltd.20200—
+11K201731Diode Laser Body Sculpture SystemShanghai Apolo Medical Technology Co., Ltd.20201—
+11K191842Discovery Pico, Discovery Pico Plus, Discovery Pico DermQuanta System Spa201918—