510(k) Report

Devices descending from K000317

240 later devices reach Spectra-VRM Q-Switched ND:Yag Laser System, Spectra-VRM through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+8K181095RF-ReliefEl Global Trade, Ltd.20181—
+8K172302InMode PLUS SystemInmode MD, Ltd.201713—
+9K261817Diode Laser Therapy System (PZ-BDT67-01, PZ-BDT67-02)Zhengzhou PZ Laser Slim Technology Co., Ltd.20260—
+9K253251Leaseir MHR Xcell (console) (MHR-100b); Handpiece: Dual (810-b and Blend-b); Handpiece…Leaseir Technologies, Slu20260—
+9K251836Dermatrix DuoShenzhen Gsd Technology Co., Ltd.20260—
+9K251981Boston PICO (Boston PICO)Boston Aesthetics, Inc.20260—
+9K250734OptiLUV DevicePollogen, Ltd.20250—
+9K250402AVAVA™ Skin Treatment SystemAVAVA, Inc.20251—
+9K243139Reverso Pro SystemIndiba S. A. U.20250—
+9K242534HandPICO Fractional Laser Handpiece TipVydence Medical20241—
+9K242598DEFINE System (AG612444A)InMode, Ltd.20240—
+9K241951Lasya-TrinityBLUECORE COMPANY Co., Ltd.20240—
+9K240386Picosecond Nd:YAG Laser Systems (BL-C10)Shanghai Bele Medical Technology Co.,Ltd20240—
+9K231896Diode Laser Therapy SystemBeijing Adss Development Co., Ltd.20240—
+9K220853PicoWay Laser SystemCandela Corporation20221—
+9K212127PicocaremajestyWontech Co., Ltd.20226—
+9K201773PicohiHironic Co., Ltd.20215—
+9K203491PicoLO Nd: YAG Picosecond Laser SystemLaseroptek Co., Ltd.20211—
+9K202503ChromeQuanta System Spa202012—
+9K183450EmBody SystemInmode MD, Ltd.20198—
+10K253829Medical Ultra-Pico Laser Treatment System (CM-SP-1064&532)Beijing HuaCheng Taike Technology Co., Ltd.20260—
+10K252753Vydence Family of LasersVydence Medical Industria E Commercio Ltda20260—
+10K252155AVAVA™ Skin Treatment SystemAVAVA, Inc.20250—
+10K250281Deka LotusEl.En S.P.A.20250—
+10K240991eMVFit (MVF-10M)Weero Co., Ltd.20240—
+10K241144Picosecond Nd:YAG Laser (PICOCAREMAJESTY)Wontech Co., Ltd.20241—
+10K233007Picosecond Nd:YAG Laser System; PICO LEGENDAmi, Inc.20241—
+10K233473Deka LotusEl.En S.P.A.20241—
+10K234104PICOANDY (Q-Switched Nd:YAG Laser)Wontech Co., Ltd.20242—
+10K233018PICOSECOND Nd:YAG Laser SystemIds, Ltd.20232—
+10K223404Duetto Suprema; Domino Suprema; Suprema VT; Suprema VT+; Suprema 4VQuanta System Spa20230—
+10K213726PL-1 Skin Treatment SystemAVAVA, Inc.20220—
+10K212573PicoLO PremiumLaseroptek Co., Ltd.20210—
+10K210877Evolve System with the T3 ApplicatorInMode, Ltd.20215—
+10K201285InMode Evolve System with the Tone ApplicatorInMode, Ltd.20216—
+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—