510(k) Report

Devices descending from K023954

1,117 later devices reach Altus Medical Coolglide Laser Systems and Accessories through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K132665Pelleve Glidesafe 10MM, 15MM & 20MM Handpiece, Pelleve S5 - IecEllman International, Inc.201317—
+5K130028Resurfx 1565NM Laser ModuleLumenis, Ltd.201341—
+5K122567Joule 810/940/980 Multi-Platform SystemSciton, Inc20136—
+5K123483Diode LaserBeijing Syntech Laser CO., LTD.201353—
+5K123777Multilaser SystemUltralight Laser Technologies, LLC20131—
+5K113504Deka Smartxide and Delivery AccessoriesEl.En Electronic Engineering Spa201312—
+5K121327Diolase 10SBiolase Technology, Inc.20132—
+5K122922E-Beam ND: Yag LaserEclipse Aesthetics, LLC20137—
+5K120622Palomar Vectus LaserPalomar Medical Technologies, Inc.20124—
+5K110375Blueshine's Gold SeriesBlueshine Srl20124—
+5K112013Evolve (R) HPD 980/1470NM Multiwavelength Diode LaserBiolitec, Inc.20126—
+5K110080Radial-Emitting Shaped Fiber Optic Delivery SystemBiolitec, Inc.201126—
+5K100610Lutronic Corporation ECO2 Plus, Denta Iii and Iii+ and SP Iii Laser SystemsLutronic Corporation20113—
+5K102755Ceralas E/ 1470NM Fiber-Coupled Diode Laser Family; Crealas HPD Multiwavelenght 980NM/…Biolitec, Inc.201046—
+5K102036Doctor Surgery Diode Lasers FamilyLambda S.P.A.20107—
+5K100143Pilot Diode Laser, Model 002-00139CAO Group, Inc.201020—
+5K094041Alpha Orthopaedics AT3 SystemAlpha Orthopaedics20100—
+5K091664GSD Intense Pulsed Light System, Models: GP666C4, GP666CShenzhen Gsd Tech Co., Ltd.20094—
+5K090399Trios SystemViora, Ltd.20090—
+5K083730IsolazAesthera Corporation20093—
+5K083682180W Cerelas D 980NM Diode Laser, Model D180Biolitec, Inc.2009121—
+5K082938EzlaseBiolase Technology, Inc.200850—
+5K082445CURATIVE980 Diode LaserOroscience, Inc.20080—
+5K082197Rhytec, Inc., Portrait PSRRhytec Incorporated20083—
+5K081015Ceralas D 980NM Diode Laser, Models D15 and D25Biolitec, Inc.200834—
+5K080118Zeltiq Aesthetics CLN1 Dermal Cooling DeviceZeltiq Aesthetics200833—
+5K073322Fox 1-980, Fox Q-1064, Fox-Q-810A.R.C Laser GmbH200822—
+6K243223Multiple therapy aesthetic treatment device (BHS 202 UNYQUE)Bh Group Us, LLC20260—
+6K261047Dental Diode Laser Device (Laser-Pen)Guilin Kevin Peter Technology Co., Ltd.20260—
+6K261817Diode Laser Therapy System (PZ-BDT67-01, PZ-BDT67-02)Zhengzhou PZ Laser Slim Technology Co., Ltd.20260—
+6K261562Diode Laser Therapy SystemSanhe LEFIS Electronics Co., Ltd.20260—
+6K253504Volnewmer™Classys, Inc.20260—
+6K253480Capenergy C Equipments RF C200 and C400 DrakarianCapenergy Medical S.L.20260—
+6K260715CurrentBody Skin LED Multi Light Therapy Mask (MK-110D)The Beauty Tech Group, Ltd.20260—
+6K253309SOGA Lasers therapy system family of Aurora handpiece (Aurora-S); SOGA Lasers therapy…Shenzhen Soga Technology Co., Ltd.20260—
+6K260688Sculpt LED Belt (HY-150A/HY-150B/HY-200A/HY-200B/HY-420A/HY-200D/HY-200C)Shenzhen Kaiyan Medical Equipment Co., Ltd.20260—
+6K253750BTL-785NEHBTL Industries, Inc.20260—
+6K260511Ulike Reglow Light Therapy Device (UM10)Shenzhen Ulike Smart Electronics Co., Ltd.20260—
+6K254197Picasso Pro Diode Laser (002-00460)CAO Group, Inc.20260—
+6K243854Contour Light (CL-100)Contour Research, LLC20261—
+6K251077JOULE 1064nm System and AccessoriesSciton, Inc20250—
+6K253054LED Light Therapy Mask (M19, M19-1, M19-2, M19-3, M19-5, M19-6)Shenzhen Xinlong Precision Plastic Mold Products Co., Ltd.20250—
+6K252786Led Light Phototherapy Bed (Pro 450/ GY-680A)Shenzhen Suyzeko Limited.20250—
+6K252845Venus Nova (FP-2001)Venus Concept, Inc.20250—
+6K252272ORA Method LED Gua Sha (GS-04)Shenzhen Kaiyan Medical Equipment Co., Ltd.20250—
+6K251727GLAM LED Facial Mask (TB-2386F)Touchbeauty Beauty & Health (Shenzhen) Co., Ltd.20250—
+6K251588LED Light Therapy Mask (FCM902, FCM905, FCM906, FCM908, 11-001-RBMASK, FCM910)Shenzhen Fittop Health Technology Co., Ltd.20252—
+6K244060eCO2 3DLutronic Corporation20250—
+6K251076Diode Laser Hair Removal Machine (models: T60A, T60B, T60C, T60D, T60E)Shenzhen Lifotronic Technology Co., Ltd.20250—
+6K250761KALA Therapy Wand (Model: KALA-03)Shenzhen Kaiyan Medical Equipment Co., Ltd.20251—
+6K250065DENSITY; DENZA; DENSITY NoirJeisys Medical Incorporated20250—
+6K243123IPL Treatment Device (MDSQMC-01)Medusa (Guangxi)Medical Devices Co., Ltd.20250—
+6K251049SurgiLight 1470 Diode Laser System (Model:Halo)Micro-Energy Medical Technology Co., Ltd.20250—
+6K250782Fractional CO2 Laser MachineZhengzhou PZ Laser Slim Technology Co., Ltd.20250—
+6K240983Discovery Pico; Discovery Pico Plus; Discovery Pico DermQuanta System Spa20251—
+6K251230The Alma Hybrid Laser SystemAlma Lasers, Inc.20250—
+6K250809Stellar M22Lumenis Be, Ltd.20250—
+6K250402AVAVA™ Skin Treatment SystemAVAVA, Inc.20251—
+6K242151Radiant Renewal Skincare Wand (HD-44,HD-44A ,HD-44B,HD-44C, HD-69, HD-69A, HD-69B)Shenzhen Nuon Medical Equipment Co., Ltd.20251—
+6K250281Deka LotusEl.En S.P.A.20250—
+6K241832Unicorn+ RF System (Unicorn+); Unicorn+ RF System (Unicorn+ I); Unicorn+ RF System…Boston Aesthetics, Inc.20251—
+6K242977308nm Excimer Phototherapy Device (CN-308E, KN-4003B3, KN-4003B4, KN-5000C KN-5000D…Xuzhou Kernel Medical Equipment Co., Ltd.20250—
+6K241270BTL-754BTL Industries, Inc.20251—
+6K243139Reverso Pro SystemIndiba S. A. U.20250—
+6K242532BTL-785BNF-EBTL Industries, Inc.20241—
+6K240897CellinewVIOL Co., Ltd.20240—
+6K242440Intense Pulsed Light Treatment System (LK-PT)Nanjing Bestview Laser S&T Co., Ltd.20240—
+6K242183Fractional CO2 Laser Therapy System (EXFU CO2)Weifang Mingliang Electronics Co., Ltd.20240—
+6K241092Youlaser PRIME; Youlaser PRIME CO2; Youlaser PRIME MTQuanta System Spa20240—
+6K241951Lasya-TrinityBLUECORE COMPANY Co., Ltd.20240—
+6K242206ActivoDaeju Meditech Engineering Co., Ltd.20240—
+6K233344Regenalase Laser SystemIpg Medical20240—
+6K240482Intense Pulsed Light System (ST-690)Smedtrum Medical Technology Co., Ltd.20241—
+6K240816MeDioStarAsclepion Laser Technologies GmbH20240—
+6K222958mJOULE RF System and AccessoriesSciton, Inc20240—
+6K233757TitanPico Laser Workstation (PICO-450)Rhein Laser Technologies Co., Ltd.20240—
+6K240313Oligio XWontech Co., Ltd.20241—
+6K231896Diode Laser Therapy SystemBeijing Adss Development Co., Ltd.20240—
+6K233143PiXel8-RevealRohrer Aesthetics20240—
+6K231910DermRays ReviveWuhan Lotuxs Technology Co., Ltd.20240—
+6K232222Primo Dental Laser (Primo, Primo Komfort, Primo Lite, Primo Blue, and Primo Triplo)Medency S.R.L.20230—
+6K232977Biophotas Celluma CONTOURBiophotas, Inc.20235—
+6K233090DEKA AGAIN PRO familyEl.En S.P.A.20232—
+6K230490PMD Clean Acne, Model: 4004-CABLUE-NA, 4004-GREY-NA, 4004-YELLOW-NA, 4004-PSTO-NA…Dongguan Hunter Electronic Technology Co., Ltd.20230—
+6K232236EchoQuanta System Spa20230—
+6K231495The Evolve System with the Transform ApplicatorInMode, Ltd.20231—
+6K231092T-Shape 2B&M S.R.L. Marketing Nel Benessere20230—
+6K232192Venus Versa PRO SystemVenus Concept, Inc.20230—
+6K223727LavieenWontech Co., Ltd.20234—
+6K223033Tixel® 2 SystemNovoxel, Ltd.20230—
+6K222790F65 Laser SystemLumenis Be, Ltd.20233—
+6K230816Intense Pulsed Light Treatment SystemShangdong Huamei Technology Co., Ltd.20231—
+6K222685NIRA Model 2Dermal Photonics Corp20230—
+6K222221Deka HelixEl.En Electronic Engineering Spa20231—
+6K221574LUDWIG Electrosurgical DeviceAesthetics Biomedical20220—
+6K221770Fiber Laser Treatment SystemShanghai Apolo Medical Technology Co., Ltd.20221—
+6K213120OW100S (model OW100S-US)Tissue Regeneration Technologies, LLC Dba AS Softwave Trt20220—
+6K213674CellFX SystemPulse Biosciences, Inc.20220—
+6K222075CellFX SystemPulse Biosciences, Inc.20220—
+6K221189Oliz LTB-1000ALtbio Co., Ltd.20220—