510(k) Report

Devices descending from K971874

816 later devices reach Sharplan Epitouch Alexandrite Laser System (5000) through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+11K181272Picocare FamilyWontech Co., Ltd.20188—
+11K180654PINXEL-RF systemRohrer Aesthetics, LLC20183—
+11K163197Cook Holmium Laser FiberCook Incorporated20170—
+11K170936Cutera enlighten III Laser SystemCutera, Inc.201710—
+11K160470SculpSureCynosure, Inc.201620—
+11K160259ZELTIQ CoolSculpting SystemZeltiq Aesthetics, Inc.201615—
+11K160513Quanta System Surgical Laser fibersQuanta System Spa201631
+11K152417Adler MicroMed Laser Surgery FibersAdler Micromed, Inc.20153—
+11K151473NaturaLase PiQo4 - NaturaLase Nd:Y AG 1064 Q-switched Laser with 532 nm accessory and…Focus Medical, LLC201537—
+11K150724SculpSureCynosure, Inc.201521—
+11K150230SculpSureCynosure, Inc.201521—
+11K111831MX-7000 MicroxelBio-Med USA, Inc.20111—
+12K261570Picosure WorkstationCynosure, LLC20260—
+12K251981Boston PICO (Boston PICO)Boston Aesthetics, Inc.20260—
+12K254290ZenTite (Unicorn+); ZenTite (Unicorn+I); ZenTite (Unicorn+II); ZenTite (Unicorn+III)Shenzhen Peninsula Medical Group20260—
+12K252369Boston Pico755Boston Aesthetics, Inc.20260—
+12K252155AVAVA™ Skin Treatment SystemAVAVA, Inc.20250—
+12K251919Thulium Laser System (Deluxlase)Nanjing Bestview Laser S&T Co., Ltd.20250—
+12K243176BLESSING SystemCellah Medical Co., Ltd.20251—
+12K243957PicoalexWontech Co., Ltd.20250—
+12K241643WONTECH Surgical Optic Fibers (BA400/BA400R/BA600/BA600R)Wontech Co., Ltd.20252—
+12K242941CO2 Laser Therapy Systems (SHE-LSP003-1)Beijing Sano Laser S&T Development Co.,Ltd20250—
+12K243147LGO-Surgical Laser FibersLight Guide Optics International, Ltd.20241—
+12K242534HandPICO Fractional Laser Handpiece TipVydence Medical20241—
+12K242688Finiff SystemSkingrab Co., Ltd.20240—
+12K231216PotenzaJeisys Medical, Inc.20244—
+12K231287PotenzaJeisys Medical, Inc.20241—
+12K240991eMVFit (MVF-10M)Weero Co., Ltd.20240—
+12K241406LavieenWontech Co., Ltd.20242—
+12K233123SilkroHironic Co., Ltd.20241—
+12K233120CWM-930S, Fixer DV9Chungwoo Co., Ltd.20240—
+12K233099GladiatorRohrer Aesthetics, LLC20240—
+12K240386Picosecond Nd:YAG Laser Systems (BL-C10)Shanghai Bele Medical Technology Co.,Ltd20240—
+12K240999Legend X Applicator VOPollogen, Ltd.20241—
+12K233849BTL-499BTL Industries, Inc.20240—
+12K233604BTL-785SBTL Industries, Inc.20243—
+12K230837PlazMagikAgnes Medical Co., Ltd.20240—
+12K232769BeaMed Laser Surgery FibersBt Beamedical Tachnoogies Ltd. (Beamed)20231—
+12K232532Nd:Yag Laser Therapy SystemsBeijing Unt Technology Co., Ltd.20230—
+12K233147PiXel8-RFRohrer Aesthetics20230—
+12K232223PlaDuo SystemShenB Co., Ltd.20230—
+12K231790The InMode System with the Morpheus8 ApplicatorsInMode, Ltd.202310—
+12K230373HELIOS 785 PicoLaseroptek Co., Ltd.20232—
+12K230819OmniGuide RFID Surgical Laser FibersOmni-Guide Holdings, Inc.20230—
+12K220853PicoWay Laser SystemCandela Corporation20221—
+12K212472AgeJetTriworks Group Srl20220—
+12K211000AcutronIlooda Co,., Ltd.20220—
+12K220793InnoVoyce Laser FiberInnovoyce, LLC20220—
+12K211681EONDominion Aesthetic Technologies, Inc.20221—
+12K212127PicocaremajestyWontech Co., Ltd.20226—
+12K201773PicohiHironic Co., Ltd.20215—
+12K210877Evolve System with the T3 ApplicatorInMode, Ltd.20215—
+12K203491PicoLO Nd: YAG Picosecond Laser SystemLaseroptek Co., Ltd.20211—
+12K201285InMode Evolve System with the Tone ApplicatorInMode, Ltd.20216—
+12K202503ChromeQuanta System Spa202012—
+12K191068Powersculp laser lipolysis systemWuhan Lotuxs Technology Co., Ltd.20196—
+12K190743Venus BlissVenus Concept USA, Inc.20194—
+12K173359Fractional CO2 Surgical Laser SystemAmi, Inc.20180—
+12K171111SculpsureCynosure, Inc.201710—
+12K162050ZELTIQ CoolSculpting SystemZeltiq Aesthetics, Inc.201614—
+12K161403A.R.C. Laser Surgical Fibers and ProbesA.R.C Laser GmbH20160—
+13K254185Potenza PrimeJeisys Medical Incorporated20260—
+13K253859Scarlet Pro (Scarlet Pro)VIOL Co., Ltd.20260—
+13K253484Lutronic GeniusCynosure Lutronic Technology Corporation20260—
+13K253542Apollo Quattro (APQ-10M)Weero Co., Ltd.20260—
+13K253803MILAN SystemLumenis Be, Ltd.20260—
+13K253750BTL-785NEHBTL Industries, Inc.20260—
+13K253829Medical Ultra-Pico Laser Treatment System (CM-SP-1064&532)Beijing HuaCheng Taike Technology Co., Ltd.20260—
+13K251435InbellaIgnite RF SystemInbella Medical, Inc.20260—
+13K252753Vydence Family of LasersVydence Medical Industria E Commercio Ltda20260—
+13K251254Ignite RF SystemInMode, Ltd.20260—
+13K252745Halo Sterile Single-use Radial Fiber…Micro-Energy Medical Technology Co., Ltd.20251—
+13K253007Laser 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—
+13K2527321927nm Thulium Laser System (PZ-DJG75-01, PZ-DJG75-02)Zhengzhou PZ Laser Slim Technology Co., Ltd.20251—
+13K252367InbellaMulti SystemInbella Medical, Inc.20250—
+13K251334New Doublo 2.0Hironic Co., Ltd.20250—
+13K241433EVE Synergy (EVE-20M)Weero Co., Ltd.20251—
+13K242469RFMagik LiteAgnes Medical Co., Ltd.20252—
+13K250113neoLaser Laser Surgery FibersG.N.S Neolaser, Ltd.20250—
+13K242532BTL-785BNF-EBTL Industries, Inc.20241—
+13K240992eMVFit (MVF-10M)Weero Co., Ltd.20240—
+13K241144Picosecond Nd:YAG Laser (PICOCAREMAJESTY)Wontech Co., Ltd.20241—
+13K233007Picosecond Nd:YAG Laser System; PICO LEGENDAmi, Inc.20241—
+13K233962ReBorn (1050nm)Lightfective, Ltd.20240—
+13K233642InMode RF SystemInMode, Ltd.20244—
+13K234104PICOANDY (Q-Switched Nd:YAG Laser)Wontech Co., Ltd.20242—
+13K233018PICOSECOND Nd:YAG Laser SystemIds, Ltd.20232—
+13K230167BACK 4Swims America Corp20230—
+13K230037BACK 3Swims America Corp20230—
+13K222226EONDominion Aesthetic Technologies, Inc.20230—
+13K223404Duetto Suprema; Domino Suprema; Suprema VT; Suprema VT+; Suprema 4VQuanta System Spa20230—
+13K222265DiosculptShanghai Wonderful Opto-Electrics Tech.Co.,Ltd20220—
+13K213726PL-1 Skin Treatment SystemAVAVA, Inc.20220—
+13K213308Venus BlissMAXVenus Concept USA, Inc.20222—
+13K212573PicoLO PremiumLaseroptek Co., Ltd.20210—
+13K212331BodySculpRohrer Aesthetics, LLC20211—
+13K211402Powersculp laser lipolysis systemLotuxs Medtech (Suzhou) Co., Ltd.20210—
+13K192970SlimusHironic Co., Ltd.20200—
+13K201731Diode Laser Body Sculpture SystemShanghai Apolo Medical Technology Co., Ltd.20201—
+13K171992SculpSureCynosure, Inc.20178—