510(k) Report

Devices descending from K981351

811 later devices reach Candela Gentlelase GL Dermatological Laser through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+10K160259ZELTIQ CoolSculpting SystemZeltiq Aesthetics, Inc.201615—
+10K160513Quanta System Surgical Laser fibersQuanta System Spa201631
+10K152417Adler MicroMed Laser Surgery FibersAdler Micromed, Inc.20153—
+10K151473NaturaLase PiQo4 - NaturaLase Nd:Y AG 1064 Q-switched Laser with 532 nm accessory and…Focus Medical, LLC201537—
+10K150724SculpSureCynosure, Inc.201521—
+10K150230SculpSureCynosure, Inc.201521—
+10K111831MX-7000 MicroxelBio-Med USA, Inc.20111—
+11K261570Picosure WorkstationCynosure, LLC20260—
+11K251981Boston PICO (Boston PICO)Boston Aesthetics, Inc.20260—
+11K254290ZenTite (Unicorn+); ZenTite (Unicorn+I); ZenTite (Unicorn+II); ZenTite (Unicorn+III)Shenzhen Peninsula Medical Group20260—
+11K252369Boston Pico755Boston Aesthetics, Inc.20260—
+11K252155AVAVA™ Skin Treatment SystemAVAVA, Inc.20250—
+11K251919Thulium Laser System (Deluxlase)Nanjing Bestview Laser S&T Co., Ltd.20250—
+11K243176BLESSING SystemCellah Medical Co., Ltd.20251—
+11K243957PicoalexWontech Co., Ltd.20250—
+11K241643WONTECH Surgical Optic Fibers (BA400/BA400R/BA600/BA600R)Wontech Co., Ltd.20252—
+11K242941CO2 Laser Therapy Systems (SHE-LSP003-1)Beijing Sano Laser S&T Development Co.,Ltd20250—
+11K243147LGO-Surgical Laser FibersLight Guide Optics International, Ltd.20241—
+11K242534HandPICO Fractional Laser Handpiece TipVydence Medical20241—
+11K242688Finiff SystemSkingrab Co., Ltd.20240—
+11K231216PotenzaJeisys Medical, Inc.20244—
+11K231287PotenzaJeisys Medical, Inc.20241—
+11K240991eMVFit (MVF-10M)Weero Co., Ltd.20240—
+11K241406LavieenWontech Co., Ltd.20242—
+11K233123SilkroHironic Co., Ltd.20241—
+11K233120CWM-930S, Fixer DV9Chungwoo Co., Ltd.20240—
+11K233099GladiatorRohrer Aesthetics, LLC20240—
+11K240386Picosecond Nd:YAG Laser Systems (BL-C10)Shanghai Bele Medical Technology Co.,Ltd20240—
+11K240999Legend X Applicator VOPollogen, Ltd.20241—
+11K233849BTL-499BTL Industries, Inc.20240—
+11K233604BTL-785SBTL Industries, Inc.20243—
+11K230837PlazMagikAgnes Medical Co., Ltd.20240—
+11K232769BeaMed Laser Surgery FibersBt Beamedical Tachnoogies Ltd. (Beamed)20231—
+11K232532Nd:Yag Laser Therapy SystemsBeijing Unt Technology Co., Ltd.20230—
+11K233147PiXel8-RFRohrer Aesthetics20230—
+11K232223PlaDuo SystemShenB Co., Ltd.20230—
+11K231790The InMode System with the Morpheus8 ApplicatorsInMode, Ltd.202310—
+11K230373HELIOS 785 PicoLaseroptek Co., Ltd.20232—
+11K230819OmniGuide RFID Surgical Laser FibersOmni-Guide Holdings, Inc.20230—
+11K220853PicoWay Laser SystemCandela Corporation20221—
+11K212472AgeJetTriworks Group Srl20220—
+11K211000AcutronIlooda Co,., Ltd.20220—
+11K220793InnoVoyce Laser FiberInnovoyce, LLC20220—
+11K211681EONDominion Aesthetic Technologies, Inc.20221—
+11K212127PicocaremajestyWontech Co., Ltd.20226—
+11K201773PicohiHironic Co., Ltd.20215—
+11K210877Evolve System with the T3 ApplicatorInMode, Ltd.20215—
+11K203491PicoLO Nd: YAG Picosecond Laser SystemLaseroptek Co., Ltd.20211—
+11K201285InMode Evolve System with the Tone ApplicatorInMode, Ltd.20216—
+11K202503ChromeQuanta System Spa202012—
+11K191068Powersculp laser lipolysis systemWuhan Lotuxs Technology Co., Ltd.20196—
+11K190743Venus BlissVenus Concept USA, Inc.20194—
+11K173359Fractional CO2 Surgical Laser SystemAmi, Inc.20180—
+11K171111SculpsureCynosure, Inc.201710—
+11K162050ZELTIQ CoolSculpting SystemZeltiq Aesthetics, Inc.201614—
+11K161403A.R.C. Laser Surgical Fibers and ProbesA.R.C Laser GmbH20160—
+12K254185Potenza PrimeJeisys Medical Incorporated20260—
+12K253859Scarlet Pro (Scarlet Pro)VIOL Co., Ltd.20260—
+12K253484Lutronic GeniusCynosure Lutronic Technology Corporation20260—
+12K253542Apollo Quattro (APQ-10M)Weero Co., Ltd.20260—
+12K253803MILAN SystemLumenis Be, Ltd.20260—
+12K253750BTL-785NEHBTL Industries, Inc.20260—
+12K253829Medical Ultra-Pico Laser Treatment System (CM-SP-1064&532)Beijing HuaCheng Taike Technology Co., Ltd.20260—
+12K251435InbellaIgnite RF SystemInbella Medical, Inc.20260—
+12K252753Vydence Family of LasersVydence Medical Industria E Commercio Ltda20260—
+12K251254Ignite RF SystemInMode, Ltd.20260—
+12K252745Halo Sterile Single-use Radial Fiber…Micro-Energy Medical Technology Co., Ltd.20251—
+12K253007Laser 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—
+12K2527321927nm Thulium Laser System (PZ-DJG75-01, PZ-DJG75-02)Zhengzhou PZ Laser Slim Technology Co., Ltd.20251—
+12K252367InbellaMulti SystemInbella Medical, Inc.20250—
+12K251334New Doublo 2.0Hironic Co., Ltd.20250—
+12K241433EVE Synergy (EVE-20M)Weero Co., Ltd.20251—
+12K242469RFMagik LiteAgnes Medical Co., Ltd.20252—
+12K250113neoLaser Laser Surgery FibersG.N.S Neolaser, Ltd.20250—
+12K242532BTL-785BNF-EBTL Industries, Inc.20241—
+12K240992eMVFit (MVF-10M)Weero Co., Ltd.20240—
+12K241144Picosecond Nd:YAG Laser (PICOCAREMAJESTY)Wontech Co., Ltd.20241—
+12K233007Picosecond Nd:YAG Laser System; PICO LEGENDAmi, Inc.20241—
+12K233962ReBorn (1050nm)Lightfective, Ltd.20240—
+12K233642InMode RF SystemInMode, Ltd.20244—
+12K234104PICOANDY (Q-Switched Nd:YAG Laser)Wontech Co., Ltd.20242—
+12K233018PICOSECOND Nd:YAG Laser SystemIds, Ltd.20232—
+12K230167BACK 4Swims America Corp20230—
+12K230037BACK 3Swims America Corp20230—
+12K222226EONDominion Aesthetic Technologies, Inc.20230—
+12K223404Duetto Suprema; Domino Suprema; Suprema VT; Suprema VT+; Suprema 4VQuanta System Spa20230—
+12K222265DiosculptShanghai Wonderful Opto-Electrics Tech.Co.,Ltd20220—
+12K213726PL-1 Skin Treatment SystemAVAVA, Inc.20220—
+12K213308Venus BlissMAXVenus Concept USA, Inc.20222—
+12K212573PicoLO PremiumLaseroptek Co., Ltd.20210—
+12K212331BodySculpRohrer Aesthetics, LLC20211—
+12K211402Powersculp laser lipolysis systemLotuxs Medtech (Suzhou) Co., Ltd.20210—
+12K192970SlimusHironic Co., Ltd.20200—
+12K201731Diode Laser Body Sculpture SystemShanghai Apolo Medical Technology Co., Ltd.20201—
+12K171992SculpSureCynosure, Inc.20178—
+12K171069ZELTIQ CoolSculpting SystemZeltiq Aesthetics, Inc.20178—
+13K260945Ultima System (UL-800);Ultimate Face Package (UL-800-Face-Set);Ultimate Shape Extension…Fit-Pro KFT (Ltd.) - DBA E-Fit20260—
+13K2615891927nm Thulium Laser System (PZ-DJG85-01, PZ-DJG85-02)Zhengzhou PZ Laser Slim Technology Co., Ltd.20260—
+13K261701Hemolase 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—
+13K250217AGNES UltraAgnes Medical Co., Ltd.20250—