510(k) Report

Devices descending from K981952

763 later devices reach Combination ND:Yag and Frequency Doubled Solid State Green Laser through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+10K213889PicoStarAsclepion Laser Technologies GmbH20220—
+10K220124YandR System, VoluDerm Handpiece, VoluDerm TipsPollogen, Ltd.20220—
+10K201685PotenzaJeisys Medical, Inc.20219—
+10K201735PlaDuo SystemShenB Co., Ltd.20203—
+10K200947InMode System with the Morhpeus8 ApplicatorsInMode, Ltd.202015—
+10K200786Venus EpileveVenus Concept USA, Inc.20200—
+10K191842Discovery Pico, Discovery Pico Plus, Discovery Pico DermQuanta System Spa201918—
+10K182355Secret RF Smartcure Applicator with electrodesIlooda Co,., Ltd.20191—
+10K183450EmBody SystemInmode MD, Ltd.20198—
+10K180654PINXEL-RF systemRohrer Aesthetics, LLC20183—
+10K173359Fractional CO2 Surgical Laser SystemAmi, Inc.20180—
+10K161403A.R.C. Laser Surgical Fibers and ProbesA.R.C Laser GmbH20160—
+11K254290ZenTite (Unicorn+); ZenTite (Unicorn+I); ZenTite (Unicorn+II); ZenTite (Unicorn+III)Shenzhen Peninsula Medical Group20260—
+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—
+11K2527321927nm Thulium Laser System (PZ-DJG75-01, PZ-DJG75-02)Zhengzhou PZ Laser Slim Technology Co., Ltd.20251—
+11K243176BLESSING SystemCellah Medical Co., Ltd.20251—
+11K250113neoLaser Laser Surgery FibersG.N.S Neolaser, Ltd.20250—
+11K242688Finiff SystemSkingrab Co., Ltd.20240—
+11K231216PotenzaJeisys Medical, Inc.20244—
+11K231287PotenzaJeisys Medical, Inc.20241—
+11K240991eMVFit (MVF-10M)Weero Co., Ltd.20240—
+11K233123SilkroHironic Co., Ltd.20241—
+11K233120CWM-930S, Fixer DV9Chungwoo Co., Ltd.20240—
+11K233099GladiatorRohrer Aesthetics, LLC20240—
+11K240999Legend X Applicator VOPollogen, Ltd.20241—
+11K233849BTL-499BTL Industries, Inc.20240—
+11K233604BTL-785SBTL Industries, Inc.20243—
+11K230837PlazMagikAgnes Medical Co., Ltd.20240—
+11K233147PiXel8-RFRohrer Aesthetics20230—
+11K232223PlaDuo SystemShenB Co., Ltd.20230—
+11K231790The InMode System with the Morpheus8 ApplicatorsInMode, Ltd.202310—
+11K212472AgeJetTriworks Group Srl20220—
+11K211000AcutronIlooda Co,., Ltd.20220—
+11K210877Evolve System with the T3 ApplicatorInMode, Ltd.20215—
+11K201285InMode Evolve System with the Tone ApplicatorInMode, Ltd.20216—
+11K202503ChromeQuanta System Spa202012—
+12K254185Potenza PrimeJeisys Medical Incorporated20260—
+12K2615891927nm Thulium Laser System (PZ-DJG85-01, PZ-DJG85-02)Zhengzhou PZ Laser Slim Technology Co., Ltd.20260—
+12K253859Scarlet Pro (Scarlet Pro)VIOL Co., Ltd.20260—
+12K253484Lutronic GeniusCynosure Lutronic Technology Corporation20260—
+12K261701Hemolase 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—
+12K253542Apollo Quattro (APQ-10M)Weero Co., Ltd.20260—
+12K253803MILAN SystemLumenis Be, Ltd.20260—
+12K253750BTL-785NEHBTL Industries, Inc.20260—
+12K251435InbellaIgnite RF SystemInbella Medical, Inc.20260—
+12K251254Ignite RF SystemInMode, Ltd.20260—
+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—
+12K242532BTL-785BNF-EBTL Industries, Inc.20241—
+12K240992eMVFit (MVF-10M)Weero Co., Ltd.20240—
+12K233642InMode RF SystemInMode, Ltd.20244—
+12K230167BACK 4Swims America Corp20230—
+12K230037BACK 3Swims America Corp20230—
+12K223404Duetto Suprema; Domino Suprema; Suprema VT; Suprema VT+; Suprema 4VQuanta System Spa20230—
+12K213726PL-1 Skin Treatment SystemAVAVA, Inc.20220—
+13K260945Ultima System (UL-800);Ultimate Face Package (UL-800-Face-Set);Ultimate Shape Extension…Fit-Pro KFT (Ltd.) - DBA E-Fit20260—
+13K250217AGNES UltraAgnes Medical Co., Ltd.20250—
+13K243713Single Use RF Surgical Electrode (Needle Type) (AN-B, AN-C, AN-E, AN-I, AN-S, AN-W3A…Agnes Medical Co., Ltd.20250—
+13K240780InMode RF SystemInMode, Ltd.20243—
+14K243737Inbella RF SystemInbella Medical, Inc.20250—