510(k) Report

Devices descending from K022884

642 later devices reach Candela Smoothbeam Laser System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+10K252367InbellaMulti SystemInbella Medical, Inc.20250—
+10K251334New Doublo 2.0Hironic Co., Ltd.20250—
+10K250734OptiLUV DevicePollogen, Ltd.20250—
+10K242469RFMagik LiteAgnes Medical Co., Ltd.20252—
+10K241643WONTECH Surgical Optic Fibers (BA400/BA400R/BA600/BA600R)Wontech Co., Ltd.20252—
+10K242941CO2 Laser Therapy Systems (SHE-LSP003-1)Beijing Sano Laser S&T Development Co.,Ltd20250—
+10K243147LGO-Surgical Laser FibersLight Guide Optics International, Ltd.20241—
+10K242532BTL-785BNF-EBTL Industries, Inc.20241—
+10K242598DEFINE System (AG612444A)InMode, Ltd.20240—
+10K242349FoLixLumenis Be, Ltd.20240—
+10K241144Picosecond Nd:YAG Laser (PICOCAREMAJESTY)Wontech Co., Ltd.20241—
+10K241459MOTUS PRO FamilyEl.En S.P.A.20240—
+10K233007Picosecond Nd:YAG Laser System; PICO LEGENDAmi, Inc.20241—
+10K233642InMode RF SystemInMode, Ltd.20244—
+10K234104PICOANDY (Q-Switched Nd:YAG Laser)Wontech Co., Ltd.20242—
+10K233018PICOSECOND Nd:YAG Laser SystemIds, Ltd.20232—
+10K232769BeaMed Laser Surgery FibersBt Beamedical Tachnoogies Ltd. (Beamed)20231—
+10K230819OmniGuide RFID Surgical Laser FibersOmni-Guide Holdings, Inc.20230—
+10K220793InnoVoyce Laser FiberInnovoyce, LLC20220—
+10K212573PicoLO PremiumLaseroptek Co., Ltd.20210—
+10K202503ChromeQuanta System Spa202012—
+10K183450EmBody SystemInmode MD, Ltd.20198—
+10K161403A.R.C. Laser Surgical Fibers and ProbesA.R.C Laser GmbH20160—
+11K260945Ultima System (UL-800);Ultimate Face Package (UL-800-Face-Set);Ultimate Shape Extension…Fit-Pro KFT (Ltd.) - DBA E-Fit20260—
+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—
+11K250217AGNES UltraAgnes Medical Co., Ltd.20250—
+11K243713Single Use RF Surgical Electrode (Needle Type) (AN-B, AN-C, AN-E, AN-I, AN-S, AN-W3A…Agnes Medical Co., Ltd.20250—
+11K250113neoLaser Laser Surgery FibersG.N.S Neolaser, Ltd.20250—
+11K240991eMVFit (MVF-10M)Weero Co., Ltd.20240—
+11K240780InMode RF SystemInMode, Ltd.20243—
+11K223404Duetto Suprema; Domino Suprema; Suprema VT; Suprema VT+; Suprema 4VQuanta System Spa20230—
+11K213726PL-1 Skin Treatment SystemAVAVA, Inc.20220—
+11K210877Evolve System with the T3 ApplicatorInMode, Ltd.20215—
+11K201285InMode Evolve System with the Tone ApplicatorInMode, Ltd.20216—
+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—
+12K241433EVE Synergy (EVE-20M)Weero Co., Ltd.20251—
+12K243737Inbella RF SystemInbella Medical, Inc.20250—
+12K240992eMVFit (MVF-10M)Weero Co., Ltd.20240—
+12K230167BACK 4Swims America Corp20230—
+12K230037BACK 3Swims America Corp20230—