meddevicedb.com FDA Device Reference

Review Panel

General, Plastic Surgery FDA 510(k) Clearances & Devices

Cleared Devices
16,323
Product Codes (page)
40
Latest Decision
2017-09-13

Clearances · page 34 of 164

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K171359 Pollogen Legend+ System Pollogen, Ltd. GEI Class II 2017-09-13
K170409 PASCAL Synthesis Twinstar Ophthalmic Scanning Laser System Topcon Medical Laser Systems, Inc. (Tmls) GEX Class II 2017-09-12
K171648 BM.IRIS Bluecore Co., Ltd. GEX Class II 2017-09-08
K170381 Minimally Invasive Sealer (MIS) Flex, Minimally Invasive Sealer (MIS) Flex Mini Medtronic Advanced Energy GEI Class II 2017-09-07
K171358 Emprint SX Ablation Platform and Accessories Coviden, LLC NEY Class II 2017-09-01
K170970 Epilaser Epilady 2000, LLC GEX Class II 2017-09-01
K171323 BIOPHOTAS CELLUMA3 Biophotas, Inc. OHS Class II 2017-09-01
K171626 truFreeze System CSA Medical, Inc. GEH Class II 2017-08-30
K172049 CryoIQ DERM, CryoIQ PRO, CryoIQ EquiMED Cry IQ AB GEH Class II 2017-08-30
K171039 Assut Filbloc Permanent Sutures Assut Europe S.P.A. GAW Class II 2017-08-29
K171561 Dextera MicroCutter 30 Blue Reload, Dextera MicroCutter 30 Curved Tip Blue Reload, Dextera MicroCutter 30 White Reload, Dextera MicroCutter 30 Curved Tip White Reload Dextera Surgical, Inc. GDW Class II 2017-08-28
K163647 Revolve Envi 600 Advanced Adipose System Lifecell Corporation MUU Class II 2017-08-25
K171921 VenaCure EVLT NeverTouch Procedure Kit AngioDynamics, Inc. GEX Class II 2017-08-24
K170984 LG BEAUTY LED MASK Lg Electronics OHS Class II 2017-08-23
K170642 GRAVITY™ Soft Tissue Repair System Wrightmedicaltechnologyinc GAT Class II 2017-08-22
K172367 Stryker Integrated Bipolar Cord and Tubing Sets Stryker Instruments GEI Class II 2017-08-22
K171523 Monopolar Single Use Laparoscopic Instrument Getsch+Hiller Medizintechnik GmbH GEI Class II 2017-08-22
K171276 Sterile Polyisoprene Surgical Powder Free Glove Tested for Use with Chemotherapy Drugs Tg Medical Sdn. Bhd. KGO Class I 2017-08-21
K171227 StarWalker Fotona D.O.O. GEX Class II 2017-08-18
K171898 Sterile Polyisoprene Powder Free Surgical Gloves, Tested for Use With Chemotherapy Drugs Better Care Plastic Technology Co., Ltd. KGO Class I 2017-08-18
K171162 Surgical Earloop Face Mask with Bottom Gap Shield and Surgical Tie-On Face Mask with Bottom Gap Shield Prestige Ameritech FXX Class II 2017-08-15
K171433 Silk'n Infinity Home Skinovations , Ltd. OHT Class II 2017-08-11
K171116 3M™ VFlex™ Health Care Particulate Respirator and Surgical Mask , Models 1804/1804S 3M Healthcare MSH Class II 2017-08-10
K170060 M22 and ResurFx Systems Lumenis, Ltd. GEX Class II 2017-08-09
K172096 Fraxis Ilooda Co,., Ltd. GEX Class II 2017-08-09
K170134 Reperen Surgical Mesh Iconlab, Inc. FTL Class II 2017-08-09
K171707 GA-B, GA-C, GA-E, GA-I, GA-S, GA-W3A, GA-F3A, GA-IL, GA-SL, GA-W3B, GA-F1A Gowoonsesang Cosmetics Co., Ltd. GEI Class II 2017-08-08
K171684 Epix Electrosurgical Probe with Smoke Evacuation Applied Medical Resources Corporation GEI Class II 2017-08-07
K170738 InMode Diolaze XL Inmode MD , Ltd. GEX Class II 2017-08-07
K171386 dpl SpectraLite Led Technologies, Inc. OHS Class II 2017-08-07
K161358 Medline ReNewal Reprocessed Stryker Neptune 2 Manifolds Surgical Instrument Service and Savings, Inc. JCX Class II 2017-08-03
K171390 dpl II Panel Led Technologies, Inc. OHS Class II 2017-08-03
K171717 AUTOCON III 400 KARL STORZ Endoscopy-America, Inc. GEI Class II 2017-08-02
K172004 truSculpt Cutera, Inc. PBX Class II 2017-08-02
K171079 Q-Switched Nd:YAG Laser System Ids, Ltd. GEX Class II 2017-08-01
K172025 Litho 60 Quanta System Spa GEX Class II 2017-07-31
K170842 WEGO-PTFE Foosin Medical Supplies Inc., Ltd. NBY Class II 2017-07-31
K171945 Discovery Pico, Discovery Pico Plus Quanta System Spa GEX Class II 2017-07-28
K170187 Photodynamic Therapy Device Uvbiotek, LLC GEX Class II 2017-07-28
K163005 TIGR Matrix Surgical Mesh Novus Scientific AB OWT Class II 2017-07-27
K172041 truFreeze System CSA Medical, Inc. GEH Class II 2017-07-27
K171255 Monteris Medical NeuroBlate System Monteris Medical, Inc. GEX Class II 2017-07-25
K170073 LightMed Dental Laser System Lightmed Dentaltechnology Corp. GEX Class II 2017-07-25
K171242 Alma LipoFlow System Alma Lasers, Inc. MUU Class II 2017-07-14
K170637 sensiFirm El Global Trade, Ltd. PBX Class II 2017-07-14
K171522 truFreeze Rapid AV Spray Kit CSA Medical, Inc. GEH Class II 2017-07-14
K162707 Single Use Circular Stapler, Single Use Hemorrhoidal Circular Stapler, Single Patient Use Linear Stapler and Reload, Single Patient Use Linear Cutter and Reload, Single Patient Use Endo Cutter and Reload, Single Patient Use Transverse Cutter and Reload Golden Stapler Surgical Co., Ltd. GDW Class II 2017-07-14
K163137 NIRA Beauty Skin Laser Dermal Photonics Corporation OHS Class II 2017-07-12
K162934 Biodesign Parastomal Hernia Repair Graft Cook Biotech Incorporated FTM Class II 2017-07-10
K171711 Thunder, Thunder VT, Thunder HR Quanta System Spa GEX Class II 2017-07-07
K160337 Safecare Open Back Protective Gowns and ValueCare Open Back Protective Gowns Bam Corporation Limited QPC Class II 2017-07-07
K171069 ZELTIQ CoolSculpting System Zeltiq Aesthetics, Inc. OOK Class II 2017-07-07
K171398 Dermal Cooling System R2 Dermatology ,Inc GEH Class II 2017-07-06
K161394 HPO Exotic, LP1, LP2, LP3, Mastersun 360, Mastersun 360 New Reflector, Vega Lux Sportarredo Group S.C. LEJ Class II 2017-07-06
K162398 CO2 Laser Therapy Systems Beijing Sincoheren Science and Technology Development Co. ONG Class II 2017-07-06
K171055 Philips BlueControl Philips Electronics Nederland B.V. ONE Class II 2017-07-06
K170871 DigniCap Scalp Cooling System Dignitana AB PMC Class II 2017-07-03
DEN160012 D2 Dressing Z-Medica, LLC POD Class II 2017-06-30
K171680 Infinity-Lock 3, Infinity-Lock 5 Xiros, Ltd. GAT Class II 2017-06-30
K163212 Parietene DS Composite Mesh Sofradim Production FTL Class II 2017-06-29
K171009 LASEMD Laser System Lutronic Corporation GEX Class II 2017-06-23
K171324 Medline ReNewal Reprocessed ArthroCare ArthroWands and Smith & Nephew Dyonics Surgical Instrument Service and Savings, Inc. NUJ Class II 2017-06-23
K163449 HyPHo Laser System Hyper Photonics Srl GEX Class II 2017-06-23
K170629 VITRUVIAN INFILTRATION PUMP Black & Black Surgical, Inc. QPB Class II 2017-06-22
K171047 Sterile Polyisoprene Powder Free Surgical Gloves Better Care Plastic Technology Co., Ltd. KGO Class I 2017-06-22
K170016 Biodesign Fistula Plug Cook Biotech Incorporated FTM Class II 2017-06-21
K163049 GOLNIT Non-Absorbable PTFE Surgical Suture Antarma Dba Golnit Sutures NBY Class II 2017-06-21
K163447 Premium Plus Disposable Barrier Sleeve Premium Plus International Limited PEM Class II 2017-06-20
K162886 DEKA MOTUS AX El.En Electronic Engineering Spa GEX Class II 2017-06-19
K163676 Silhouette InstaLift Silhouette Lift, Inc. GAM Class II 2017-06-16
K162659 Diode Laser Hair Removal System Shandong Huamei Technology Co., Ltd. GEX Class II 2017-06-16
K170198 Cardinal Health Sterile Polyisoprene Blend Powder-Free Surgical Gloves, Tested for Use with Chemotherapy Drugs (White) Cardinal Health, Inc. KGO Class I 2017-06-15
K170850 Alma Q Alma Lasers , Ltd. GEX Class II 2017-06-15
K170499 sensiLift El Global Trade, Ltd. PAY Class II 2017-06-15
K171494 TroClose1200, TroClose1200 Cannula Gordian Surgical, Ltd. GAM Class II 2017-06-15
K170803 HydroMARK Breast Biopsy Site Markers Devicor Medical Products, Inc. NEU Class II 2017-06-15
K170325 SECRET RF Ilooda Co,., Ltd. GEI Class II 2017-06-13
K171111 Sculpsure Cynosure, Inc. PKT Class II 2017-06-13
K162755 Picocare Wontech Co., Ltd. GEX Class II 2017-06-12
K170515 Sterile Nitrile Surgical Gloves, Powder-free Primus Gloves Pvt Limited KGO Class I 2017-06-09
K170762 Cardinal Health Non-Reinforced Surgical Gown Cardinal Health200, LLC FYA Class II 2017-06-09
K171066 BiZact Tonsillectomy Device Advanced Bipolar Tissue Sealer/Divider Covidien, LLC GEI Class II 2017-06-08
K162610 NEXA Negative Pressure Wound Therapy System Nexa Medical , Ltd. OMP Class II 2017-06-08
K170661 Novosyn Quick Absorbable Suture Aesculap, Inc. GAM Class II 2017-06-08
K170763 Gentrix Surgical Matrix Thick; Gentrix Surgical Matrix Extend Acell, Inc. FTM Class II 2017-06-08
K170366 Laser Peripherals, LLC Family of Bare Laser Fibers Laser Peripherals, LLC GEX Class II 2017-06-08
K171357 SurgiMend PRS Meshed, Revize-X Integra Lifesciences Corporation (Owner of Tei Biosciences) OXH Class II 2017-06-07
K170709 CURVE Laser System Yolo Medical, Inc. OLI Class II 2017-06-06
K171429 Magnetic Surgical System Levita Magnetics International Corp PNL Class II 2017-06-06
K170026 Radiopaque Tissue Marker Viscus Biologics, LLC NEU Class II 2017-06-02
K163639 LS-5 ePTFE Suture Lsi Solutions NBY Class II 2017-06-02
K170278 OptiFix AT Absorbable Fixation System with Articulating Technology - 30 Fasteners, OptiFix AT Absorbable Fixation System with Articulating Technology - 15 Fasteners C.R. Bard, Inc. GDW Class II 2017-05-31
K170626 Modified Alma Lasers Soprano XL Family of Multi-Application & Multi-Technology Platform, Soprano YAG Hand piece Alma Lasers, Inc. GEX Class II 2017-05-31
K170178 Ultravision Visual Field Clearing System Alesi Surgical, Ltd. PQM Class II 2017-05-26
K171296 SutureTape Arthrex, Inc. GAT Class II 2017-05-26
K170597 PicoWay Laser System Syneron Candela Corporation GEX Class II 2017-05-25
K163196 ACTION II Laser System Lutronic Corporation GEX Class II 2017-05-24
K163244 truFreeze System CSA Medical, Inc. GEH Class II 2017-05-24
K163197 Cook Holmium Laser Fiber Cook Incorporated GEX Class II 2017-05-24
K170489 Skylit Phototherapy System Skylit Medical FTC Class II 2017-05-23

16,323 clearances in the General, Plastic Surgery panel. Data: openFDA.