510(k) Report

Devices descending from K912703

728 later devices reach Optica 60 ND;Yag Surgical Laser System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+12K232769BeaMed Laser Surgery FibersBt Beamedical Tachnoogies Ltd. (Beamed)20231—
+12K232532Nd:Yag Laser Therapy SystemsBeijing Unt Technology Co., Ltd.20230—
+12K230819OmniGuide RFID Surgical Laser FibersOmni-Guide Holdings, Inc.20230—
+12K220268Picosecond Laser System (Model PS10-A and PS10-B)Beijing Adss Development Co., Ltd.20221—
+12K220793InnoVoyce Laser FiberInnovoyce, LLC20220—
+12K213889PicoStarAsclepion Laser Technologies GmbH20220—
+12K212573PicoLO PremiumLaseroptek Co., Ltd.20210—
+12K210877Evolve System with the T3 ApplicatorInMode, Ltd.20215—
+12K201285InMode Evolve System with the Tone ApplicatorInMode, Ltd.20216—
+12K191842Discovery Pico, Discovery Pico Plus, Discovery Pico DermQuanta System Spa201918—
+12K161403A.R.C. Laser Surgical Fibers and ProbesA.R.C Laser GmbH20160—
+13K260945Ultima System (UL-800);Ultimate Face Package (UL-800-Face-Set);Ultimate Shape Extension…Fit-Pro KFT (Ltd.) - DBA E-Fit20260—
+13K253542Apollo Quattro (APQ-10M)Weero Co., 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—
+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—
+13K241433EVE Synergy (EVE-20M)Weero Co., Ltd.20251—
+13K250113neoLaser Laser Surgery FibersG.N.S Neolaser, Ltd.20250—
+13K240992eMVFit (MVF-10M)Weero Co., Ltd.20240—
+13K240780InMode RF SystemInMode, Ltd.20243—
+13K230167BACK 4Swims America Corp20230—
+13K230037BACK 3Swims America Corp20230—
+13K202503ChromeQuanta System Spa202012—
+14K261701Hemolase 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—
+14K243737Inbella RF SystemInbella Medical, Inc.20250—
+14K223404Duetto Suprema; Domino Suprema; Suprema VT; Suprema VT+; Suprema 4VQuanta System Spa20230—
+14K213726PL-1 Skin Treatment SystemAVAVA, Inc.20220—