510(k) Report

Devices descending from K885025

333 later devices reach Houva II Uva through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+10K243139Reverso Pro SystemIndiba S. A. U.20250—
+10K242598DEFINE System (AG612444A)InMode, 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—
+10K240752Deka ToroEl.En S.P.A.20240—
+10K240118Picosecond Nd:YAG Laser SystemSmedtrum Medical Technology Co., Ltd.20240—
+10K234104PICOANDY (Q-Switched Nd:YAG Laser)Wontech Co., Ltd.20242—
+10K233018PICOSECOND Nd:YAG Laser SystemIds, Ltd.20232—
+10K220268Picosecond Laser System (Model PS10-A and PS10-B)Beijing Adss Development Co., Ltd.20221—
+10K212573PicoLO PremiumLaseroptek Co., Ltd.20210—
+10K183450EmBody SystemInmode MD, Ltd.20198—
+10K171945Discovery Pico, Discovery Pico PlusQuanta System Spa201721—
+11K240991eMVFit (MVF-10M)Weero Co., Ltd.20240—
+11K210877Evolve System with the T3 ApplicatorInMode, Ltd.20215—
+11K201285InMode Evolve System with the Tone ApplicatorInMode, Ltd.20216—
+11K172376Discovery Pico, Discovery Pico PlusQuanta System Spa201720—
+12K253542Apollo Quattro (APQ-10M)Weero Co., Ltd.20260—
+12K241433EVE Synergy (EVE-20M)Weero Co., Ltd.20251—
+12K240992eMVFit (MVF-10M)Weero Co., Ltd.20240—
+12K230167BACK 4Swims America Corp20230—
+12K230037BACK 3Swims America Corp20230—
+12K213889PicoStarAsclepion Laser Technologies GmbH20220—
+12K191842Discovery Pico, Discovery Pico Plus, Discovery Pico DermQuanta System Spa201918—
+13K202503ChromeQuanta System Spa202012—
+14K253765Vanish ProDdc Technologies, Inc.20260—
+14K250281Deka LotusEl.En S.P.A.20250—
+14K241527Pastelle ProWontech Co., Ltd.20253—
+14K233473Deka LotusEl.En S.P.A.20241—
+14K223404Duetto Suprema; Domino Suprema; Suprema VT; Suprema VT+; Suprema 4VQuanta System Spa20230—
+14K213726PL-1 Skin Treatment SystemAVAVA, Inc.20220—
+14K213569HOLLYWOOD SPECTRA Laser SystemLutronic Corporation20227—
+15K251464TRI-BEAM PRO, TRI-BEAM (Nd:YAG Laser unit)Jeisys Medical Incorporated20250—