510(k) Report

Devices descending from K030426

563 later devices reach Omnilux Red through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+8K243957PicoalexWontech Co., Ltd.20250—
+8K242534HandPICO Fractional Laser Handpiece TipVydence Medical20241—
+8K243040LED Light Therapy Mask…Shenzhen Siken 3D Technology Development Co., Ltd.20241—
+8K241407Splendor X (Alex, Alex2, Nd:YAG, Alex+Nd:YAG)Bios S.R.L.20240—
+8K240386Picosecond Nd:YAG Laser Systems (BL-C10)Shanghai Bele Medical Technology Co.,Ltd20240—
+8K240396Elite iQ PRO (M122K1)Cynosure, LLC20240—
+8K233114LED silicone mask (Model: LP-RVTGLWP-WHT, LP-RVTGLW-WHT, TLM200)Shenzhen Idea Light Limited20241—
+8K230373HELIOS 785 PicoLaseroptek Co., Ltd.20232—
+8K220853PicoWay Laser SystemCandela Corporation20221—
+8K214015Palm NRG cellulite body device (model: Palm NRG body device)Heat IN A Click, LLC20220—
+8K214103Shani Darden LED light therapy maskHarpar Grace International202219—
+8K212127PicocaremajestyWontech Co., Ltd.20226—
+8K201773PicohiHironic Co., Ltd.20215—
+8K211821DEKA Motus AZEl.En Electronic Engineering Spa20211—
+8K203491PicoLO Nd: YAG Picosecond Laser SystemLaseroptek Co., Ltd.20211—
+8K200116PicoSecond Nd: YAG Laser SystemShanghai Apolo Medical Technology Co., Ltd.20206—
+8K191855EmFace DeviceInmode MD, Ltd.20191—
+8K181095RF-ReliefEl Global Trade, Ltd.20181—
+8K173677InMode VLazeInmode MD, Ltd.20183—
+8K172302InMode PLUS SystemInmode MD, Ltd.201713—
+8K171711Thunder, Thunder VT, Thunder HRQuanta System Spa20170—
+8K163222Discovery Pico FamilyQuanta System Spa201630—
+9K260017Picosecond Nd:YAG Laser Systems (Model: HS-298)Shanghai Apolo Medical Technology Co., Ltd.20260—
+9K253829Medical Ultra-Pico Laser Treatment System (CM-SP-1064&532)Beijing HuaCheng Taike Technology Co., Ltd.20260—
+9K251836Dermatrix DuoShenzhen Gsd Technology Co., Ltd.20260—
+9K252753Vydence Family of LasersVydence Medical Industria E Commercio Ltda20260—
+9K252447Picosecond laser device (BMPS4)Hebei Newangie Technology Co., Ltd.20250—
+9K250734OptiLUV DevicePollogen, Ltd.20250—
+9K250041Medical Picosecond ND: YAG Laser System (PZ-6)Zhengzhou PZ Laser Slim Technology Co., Ltd.20250—
+9K243139Reverso Pro SystemIndiba S. A. U.20250—
+9K242598DEFINE System (AG612444A)InMode, Ltd.20240—
+9K241144Picosecond Nd:YAG Laser (PICOCAREMAJESTY)Wontech Co., Ltd.20241—
+9K241459MOTUS PRO FamilyEl.En S.P.A.20240—
+9K233007Picosecond Nd:YAG Laser System; PICO LEGENDAmi, Inc.20241—
+9K240752Deka ToroEl.En S.P.A.20240—
+9K240118Picosecond Nd:YAG Laser SystemSmedtrum Medical Technology Co., Ltd.20240—
+9K234104PICOANDY (Q-Switched Nd:YAG Laser)Wontech Co., Ltd.20242—
+9K233018PICOSECOND Nd:YAG Laser SystemIds, Ltd.20232—
+9K230124LUSTRE ClearSkin Renew Pro Facewear Mask (Model: PR4001)Light Tree Ventures Europe B.V.202310—
+9K220268Picosecond Laser System (Model PS10-A and PS10-B)Beijing Adss Development Co., Ltd.20221—
+9K212573PicoLO PremiumLaseroptek Co., Ltd.20210—
+9K183450EmBody SystemInmode MD, Ltd.20198—
+9K171945Discovery Pico, Discovery Pico PlusQuanta System Spa201721—
+10K240991eMVFit (MVF-10M)Weero Co., Ltd.20240—
+10K210877Evolve System with the T3 ApplicatorInMode, Ltd.20215—
+10K201285InMode Evolve System with the Tone ApplicatorInMode, Ltd.20216—
+10K172376Discovery Pico, Discovery Pico PlusQuanta System Spa201720—
+11K253542Apollo Quattro (APQ-10M)Weero Co., Ltd.20260—
+11K241433EVE Synergy (EVE-20M)Weero Co., Ltd.20251—
+11K240992eMVFit (MVF-10M)Weero Co., Ltd.20240—
+11K230167BACK 4Swims America Corp20230—
+11K230037BACK 3Swims America Corp20230—
+11K213889PicoStarAsclepion Laser Technologies GmbH20220—
+11K191842Discovery Pico, Discovery Pico Plus, Discovery Pico DermQuanta System Spa201918—
+12K202503ChromeQuanta System Spa202012—
+13K253765Vanish ProDdc Technologies, Inc.20260—
+13K250281Deka LotusEl.En S.P.A.20250—
+13K241527Pastelle ProWontech Co., Ltd.20253—
+13K233473Deka LotusEl.En S.P.A.20241—
+13K223404Duetto Suprema; Domino Suprema; Suprema VT; Suprema VT+; Suprema 4VQuanta System Spa20230—
+13K213726PL-1 Skin Treatment SystemAVAVA, Inc.20220—
+13K213569HOLLYWOOD SPECTRA Laser SystemLutronic Corporation20227—
+14K251464TRI-BEAM PRO, TRI-BEAM (Nd:YAG Laser unit)Jeisys Medical Incorporated20250—