510(k) Report

Devices descending from K003202

759 later devices reach Family of Altus Medical Coolglide Aesthetic Lasers, Models I & II through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+10K241406LavieenWontech Co., Ltd.20242—
+10K233123SilkroHironic Co., Ltd.20241—
+10K241459MOTUS PRO FamilyEl.En S.P.A.20240—
+10K233120CWM-930S, Fixer DV9Chungwoo Co., Ltd.20240—
+10K233099GladiatorRohrer Aesthetics, LLC20240—
+10K240386Picosecond Nd:YAG Laser Systems (BL-C10)Shanghai Bele Medical Technology Co.,Ltd20240—
+10K240999Legend X Applicator VOPollogen, Ltd.20241—
+10K233849BTL-499BTL Industries, Inc.20240—
+10K233604BTL-785SBTL Industries, Inc.20243—
+10K230837PlazMagikAgnes Medical Co., Ltd.20240—
+10K232532Nd:Yag Laser Therapy SystemsBeijing Unt Technology Co., Ltd.20230—
+10K233147PiXel8-RFRohrer Aesthetics20230—
+10K232223PlaDuo SystemShenB Co., Ltd.20230—
+10K231790The InMode System with the Morpheus8 ApplicatorsInMode, Ltd.202310—
+10K230373HELIOS 785 PicoLaseroptek Co., Ltd.20232—
+10K220853PicoWay Laser SystemCandela Corporation20221—
+10K212472AgeJetTriworks Group Srl20220—
+10K211000AcutronIlooda Co,., Ltd.20220—
+10K212127PicocaremajestyWontech Co., Ltd.20226—
+10K201773PicohiHironic Co., Ltd.20215—
+10K210877Evolve System with the T3 ApplicatorInMode, Ltd.20215—
+10K203491PicoLO Nd: YAG Picosecond Laser SystemLaseroptek Co., Ltd.20211—
+10K201285InMode Evolve System with the Tone ApplicatorInMode, Ltd.20216—
+10K202503ChromeQuanta System Spa202012—
+10K173359Fractional CO2 Surgical Laser SystemAmi, Inc.20180—
+11K254185Potenza PrimeJeisys Medical Incorporated20260—
+11K253859Scarlet Pro (Scarlet Pro)VIOL Co., Ltd.20260—
+11K253484Lutronic GeniusCynosure Lutronic Technology Corporation20260—
+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—
+11K253803MILAN SystemLumenis Be, Ltd.20260—
+11K253750BTL-785NEHBTL Industries, Inc.20260—
+11K253829Medical Ultra-Pico Laser Treatment System (CM-SP-1064&532)Beijing HuaCheng Taike Technology Co., Ltd.20260—
+11K251435InbellaIgnite RF SystemInbella Medical, Inc.20260—
+11K252753Vydence Family of LasersVydence Medical Industria E Commercio Ltda20260—
+11K251254Ignite RF SystemInMode, Ltd.20260—
+11K2527321927nm Thulium Laser System (PZ-DJG75-01, PZ-DJG75-02)Zhengzhou PZ Laser Slim Technology Co., Ltd.20251—
+11K252367InbellaMulti SystemInbella Medical, Inc.20250—
+11K251334New Doublo 2.0Hironic Co., Ltd.20250—
+11K241433EVE Synergy (EVE-20M)Weero Co., Ltd.20251—
+11K242469RFMagik LiteAgnes Medical Co., Ltd.20252—
+11K242532BTL-785BNF-EBTL Industries, Inc.20241—
+11K240992eMVFit (MVF-10M)Weero Co., Ltd.20240—
+11K241144Picosecond Nd:YAG Laser (PICOCAREMAJESTY)Wontech Co., Ltd.20241—
+11K233007Picosecond Nd:YAG Laser System; PICO LEGENDAmi, Inc.20241—
+11K233642InMode RF SystemInMode, Ltd.20244—
+11K234104PICOANDY (Q-Switched Nd:YAG Laser)Wontech Co., Ltd.20242—
+11K233018PICOSECOND Nd:YAG Laser SystemIds, Ltd.20232—
+11K230167BACK 4Swims America Corp20230—
+11K230037BACK 3Swims America Corp20230—
+11K223404Duetto Suprema; Domino Suprema; Suprema VT; Suprema VT+; Suprema 4VQuanta System Spa20230—
+11K213726PL-1 Skin Treatment SystemAVAVA, Inc.20220—
+11K212573PicoLO PremiumLaseroptek Co., Ltd.20210—
+12K260945Ultima System (UL-800);Ultimate Face Package (UL-800-Face-Set);Ultimate Shape Extension…Fit-Pro KFT (Ltd.) - DBA E-Fit20260—
+12K2615891927nm Thulium Laser System (PZ-DJG85-01, PZ-DJG85-02)Zhengzhou PZ Laser Slim Technology Co., Ltd.20260—
+12K250217AGNES UltraAgnes Medical Co., Ltd.20250—
+12K243713Single Use RF Surgical Electrode (Needle Type) (AN-B, AN-C, AN-E, AN-I, AN-S, AN-W3A…Agnes Medical Co., Ltd.20250—
+12K240780InMode RF SystemInMode, Ltd.20243—
+13K243737Inbella RF SystemInbella Medical, Inc.20250—