510(k) Report

Devices descending from K031988

450 later devices reach Aurora DS through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+9K213267Dynamis Pro FamilyFotona D.O.O.20222—
+9K220793InnoVoyce Laser FiberInnovoyce, LLC20220—
+9K213350mJOULE System and AccessoriesSciton, Inc20220—
+9K202288FinebeamSNJ Co., Ltd.20212—
+9K210350Gemini 2 810+980 Soft Tissue LaserAzena Medical, LLC20211—
+9K212607DarwinLuvo Medical Technologies, Inc.20210—
+9K203788DermaV Laser SystemLutronic Corporation202101
+9K202985LightWalker Laser System FamilyFotona D.O.O.20217—
+9K201387Ultrafast, Ultrafast Plus, Ultrafast LiteDentlight, Inc.20210—
+9K202172StarWalkerFotona D.O.O.20203—
+9K192856MT OneM&T S.R.L.20202—
+9K193661LightWalker Laser System FamilyFotona D.O.O.20208—
+9K192539Deka LuxeaEl.En Electronic Engineering Spa20194—
+9K191942MT One DiamondM&T S.R.L.20191—
+9K183156V-LaserWontech Co., Ltd.20193—
+9K182741SculpSureCynosure20195—
+9K181518Sebacia MicroparticlesSebacia, Inc.20180—
+9K172771Epic Pro 940Biolase, Inc.20171—
+9K172413MT ONEM&T S.R.L.20175—
+9K170626Modified Alma Lasers Soprano XL Family of Multi-Application & Multi-Technology Platform…Alma Lasers, Inc.201724—
+9K161403A.R.C. Laser Surgical Fibers and ProbesA.R.C Laser GmbH20160—
+10K252723Dynamis Pro FamilyFotona D.O.O.20260—
+10K261817Diode Laser Therapy System (PZ-BDT67-01, PZ-BDT67-02)Zhengzhou PZ Laser Slim Technology Co., Ltd.20260—
+10K260138LUNE PureHygieneEnamel Pure20260—
+10K260256Q-Switched Nd: YAG Laser SystemsShanghai Apolo Medical Technology Co., Ltd.20260—
+10K260765Gemini NOVA 810+980 Soft Tissue LaserAzena Medical, LLC20260—
+10K253342PICO-KSpeclipse, Inc.20251—
+10K252745Halo Sterile Single-use Radial Fiber…Micro-Energy Medical Technology Co., Ltd.20251—
+10K253344Bellus-QSpeclipse, Inc.20250—
+10K253007Laser 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—
+10K242755Medical Diode Laser Systems (VELAS II-30B, VELAS II-30A, GBOX-15AB, GBOX-20B, CHEESE…Gigaalaser Company, Ltd.20251—
+10K251094Alma VeilWontech Co., Ltd.20250—
+10K250113neoLaser Laser Surgery FibersG.N.S Neolaser, Ltd.20250—
+10K243780HELIOS 785 Pico (1754V2)Laseroptek Co., Ltd.20250—
+10K242941CO2 Laser Therapy Systems (SHE-LSP003-1)Beijing Sano Laser S&T Development Co.,Ltd20250—
+10K241951Lasya-TrinityBLUECORE COMPANY Co., Ltd.20240—
+10K242202LightWalker Laser System FamilyFotona D.O.O.20241—
+10K233849BTL-499BTL Industries, Inc.20240—
+10K231896Diode Laser Therapy SystemBeijing Adss Development Co., Ltd.20240—
+10K231131Diode Laser Body Sculpture SystemsShanghai Bele Medical Technology Co.,Ltd20230—
+10K22079410PLTentech Co., Ltd.20220—
+10K221427V-LaserWontech Co., Ltd.20222—
+10K212790XLase PlusBiotec Italia, Srl20220—
+10K203395Platform treatment systemShanghai Apolo Medical Technology Co., Ltd.20221—
+10K200736Stardust MedI.T.S. Group S.R.L.20200—
+10K200616E>EyeCE-Swin20200—
+10K191162EpiLaze Multi-wavelength LaserRohrer Aesthetics, LLC20190—
+11K261701Hemolase 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—
+11K261214Pico Shining (Pico-K; Picofy)Speclipse, Inc.20260—
+11K253965CureLight Medical Diode Laser Systems (CureLight F2-A15; CureLight F2-B15; CureLight…Wuhan PHOMED Technology Company, Ltd.20260—