510(k) Report

Devices descending from K984110

1,034 later devices reach Laserscope Coolspot through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+9K153566Magma SystemFormatk Systems, Ltd.20162—
+9K160513Quanta System Surgical Laser fibersQuanta System Spa201631
+9K152417Adler MicroMed Laser Surgery FibersAdler Micromed, Inc.20153—
+9K122020Photon Photon PlusZolar Technology & Mfg Co., Inc.20134—
+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—
+10K253309SOGA Lasers therapy system family of Aurora handpiece (Aurora-S); SOGA Lasers therapy…Shenzhen Soga Technology Co., Ltd.20260—
+10K261214Pico Shining (Pico-K; Picofy)Speclipse, Inc.20260—
+10K260017Picosecond Nd:YAG Laser Systems (Model: HS-298)Shanghai Apolo Medical Technology Co., Ltd.20260—
+10K253829Medical Ultra-Pico Laser Treatment System (CM-SP-1064&532)Beijing HuaCheng Taike Technology Co., Ltd.20260—
+10K254290ZenTite (Unicorn+); ZenTite (Unicorn+I); ZenTite (Unicorn+II); ZenTite (Unicorn+III)Shenzhen Peninsula Medical Group20260—
+10K252753Vydence Family of LasersVydence Medical Industria E Commercio Ltda20260—
+10K250731MateLaser Medical Diode Laser Systems (ML-DLS-30)Matelaser, Inc.20250—
+10K252447Picosecond laser device (BMPS4)Hebei Newangie Technology Co., Ltd.20250—
+10K252096Light Therapy Decollete Mask (1019135)Merchsource, LLC20250—
+10K250734OptiLUV DevicePollogen, Ltd.20250—
+10K250966CurrentBody Skin™ LED Light Therapy Mask Series 2 (MK-90H)Shenzhen Kaiyan Medical Equipment Co., Ltd.20250—
+10K251230The Alma Hybrid Laser SystemAlma Lasers, Inc.20250—
+10K243176BLESSING SystemCellah Medical Co., Ltd.20251—
+10K250041Medical Picosecond ND: YAG Laser System (PZ-6)Zhengzhou PZ Laser Slim Technology Co., Ltd.20250—
+10K243764Medical Diode Laser (UTU3-F7B,UTU3-F7W,UTU3-G7B,UTU3-G7W,UTU-G20B,UTU-G20W)Wuhan Pioon Technology Co., Ltd.20250—
+10K250809Stellar M22Lumenis Be, Ltd.20250—
+10K242068LED Light Therapy Mask (RT01)Ningbo Dechang Electrical Machinery Made Co.,Ltd20250—
+10K241643WONTECH Surgical Optic Fibers (BA400/BA400R/BA600/BA600R)Wontech Co., Ltd.20252—
+10K243147LGO-Surgical Laser FibersLight Guide Optics International, Ltd.20241—
+10K242688Finiff SystemSkingrab Co., Ltd.20240—
+10K243040LED Light Therapy Mask…Shenzhen Siken 3D Technology Development Co., Ltd.20241—
+10K241670Fractional CO2 Laser Therapy System (FG900-S); Fractional CO2 Laser Therapy System…Beijing Adss Development Co., Ltd.20241—
+10K231216PotenzaJeisys Medical, Inc.20244—
+10K242598DEFINE System (AG612444A)InMode, Ltd.20240—
+10K231287PotenzaJeisys Medical, Inc.20241—
+10K241144Picosecond Nd:YAG Laser (PICOCAREMAJESTY)Wontech Co., Ltd.20241—
+10K233123SilkroHironic Co., Ltd.20241—
+10K241459MOTUS PRO FamilyEl.En S.P.A.20240—
+10K233007Picosecond Nd:YAG Laser System; PICO LEGENDAmi, Inc.20241—
+10K233120CWM-930S, Fixer DV9Chungwoo Co., Ltd.20240—
+10K233099GladiatorRohrer Aesthetics, LLC20240—
+10K240752Deka ToroEl.En S.P.A.20240—
+10K240999Legend X Applicator VOPollogen, Ltd.20241—
+10K240118Picosecond Nd:YAG Laser SystemSmedtrum Medical Technology Co., Ltd.20240—
+10K233849BTL-499BTL Industries, Inc.20240—
+10K233962ReBorn (1050nm)Lightfective, Ltd.20240—
+10K233604BTL-785SBTL Industries, Inc.20243—
+10K234085LUNE™ PureHygieneEnamel Pure20241—
+10K234104PICOANDY (Q-Switched Nd:YAG Laser)Wontech Co., Ltd.20242—
+10K230047Medical Diode Laser SystemsGigaalaser Company, Ltd.20242—
+10K230837PlazMagikAgnes Medical Co., Ltd.20240—
+10K233143PiXel8-RevealRohrer Aesthetics20240—
+10K233114LED silicone mask (Model: LP-RVTGLWP-WHT, LP-RVTGLW-WHT, TLM200)Shenzhen Idea Light Limited20241—
+10K233018PICOSECOND Nd:YAG Laser SystemIds, Ltd.20232—
+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—
+10K230819OmniGuide RFID Surgical Laser FibersOmni-Guide Holdings, Inc.20230—
+10K222226EONDominion Aesthetic Technologies, Inc.20230—
+10K222221Deka HelixEl.En Electronic Engineering Spa20231—
+10K221770Fiber Laser Treatment SystemShanghai Apolo Medical Technology Co., Ltd.20221—
+10K222265DiosculptShanghai Wonderful Opto-Electrics Tech.Co.,Ltd20220—
+10K220268Picosecond Laser System (Model PS10-A and PS10-B)Beijing Adss Development Co., Ltd.20221—
+10K212472AgeJetTriworks Group Srl20220—
+10K211000AcutronIlooda Co,., Ltd.20220—
+10K220793InnoVoyce Laser FiberInnovoyce, LLC20220—
+10K214103Shani Darden LED light therapy maskHarpar Grace International202219—
+10K213308Venus BlissMAXVenus Concept USA, Inc.20222—
+10K212573PicoLO PremiumLaseroptek Co., Ltd.20210—
+10K210350Gemini 2 810+980 Soft Tissue LaserAzena Medical, LLC20211—
+10K212331BodySculpRohrer Aesthetics, LLC20211—
+10K211402Powersculp laser lipolysis systemLotuxs Medtech (Suzhou) Co., Ltd.20210—
+10K201387Ultrafast, Ultrafast Plus, Ultrafast LiteDentlight, Inc.20210—
+10K192970SlimusHironic Co., Ltd.20200—
+10K201731Diode Laser Body Sculpture SystemShanghai Apolo Medical Technology Co., Ltd.20201—
+10K183450EmBody SystemInmode MD, Ltd.20198—
+10K172771Epic Pro 940Biolase, Inc.20171—
+10K171992SculpSureCynosure, Inc.20178—
+10K171945Discovery Pico, Discovery Pico PlusQuanta System Spa201721—
+10K171069ZELTIQ CoolSculpting SystemZeltiq Aesthetics, Inc.20178—
+10K162781Magma SparkFormatk Systems, Ltd.20160—
+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—
+11K253750BTL-785NEHBTL Industries, Inc.20260—
+11K260765Gemini NOVA 810+980 Soft Tissue LaserAzena Medical, LLC20260—
+11K251435InbellaIgnite RF SystemInbella Medical, Inc.20260—
+11K251254Ignite RF SystemInMode, 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—
+11K251334New Doublo 2.0Hironic Co., Ltd.20250—
+11K242755Medical Diode Laser Systems (VELAS II-30B, VELAS II-30A, GBOX-15AB, GBOX-20B, CHEESE…Gigaalaser Company, Ltd.20251—
+11K242469RFMagik LiteAgnes Medical Co., Ltd.20252—
+11K250113neoLaser Laser Surgery FibersG.N.S Neolaser, Ltd.20250—
+11K242941CO2 Laser Therapy Systems (SHE-LSP003-1)Beijing Sano Laser S&T Development Co.,Ltd20250—
+11K242532BTL-785BNF-EBTL Industries, Inc.20241—
+11K240991eMVFit (MVF-10M)Weero Co., Ltd.20240—