meddevicedb.com FDA Device Reference

Review Panel

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

Cleared Devices
16,323
Product Codes (page)
41
Latest Decision
2018-01-30

Clearances · page 33 of 164

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K173436 Luma Light System Luma Therapeutics FTC Class II 2018-01-30
K173285 JOULE SYSTEM Sciton, Inc GEX Class II 2018-01-29
K171391 Stryker 90-S Max SERFAS Energy Probe Stryker GEI Class II 2018-01-26
K173062 Non Woven Face Mask (Models: VQN0185W (earloop) and VQN0185B (ties)) V&Q Manufacturing Corporation FXX Class II 2018-01-25
K163684 C2 CryoBalloon Ablation System C2 Therapeutics, Inc. GEH Class II 2018-01-23
K172791 Lumilisse IPL Hair Remover Conair Corporation OHT Class II 2018-01-18
K173582 ThermiX Temperature Control Radiofrequency System, Accessories - RF Electrodes Thermigen, L.L.C GEI Class II 2018-01-17
K172193 Modified Alma Lasers Soprano XL™ Family ofMulti-Application & Multi-Technology Platforms [SopranoXL, SopranoXLi, SopranoICE and Soprano ICE Platinum] with Duo and Trio Diode Laser Modules., Soprano Duo and Trio Diode Laser Modules Alma Lasers, Inc. GEX Class II 2018-01-09
K172662 reVive Perioral Led Technologies, Inc. OHS Class II 2018-01-09
K173759 Thermage CPT System and Accessories Solta Medical GEI Class II 2018-01-08
K172942 Pristeen (Latex Surgeon’s Gloves Powder Free, Polymer coated with protein content labeling claim of 50 ug/dm2 or less per glove of extractable protein Beta Healthcare Products Pvt., Ltd. KGO Class I 2018-01-08
DEN160037 dermaPACE System Sanuwave, Inc. PZL Class II 2017-12-28
DEN170024 AQUABEAM System Procept Biorobotics, Corporation PZP Class II 2017-12-21
K172960 easyEndoTM Linear Cutting Stapler and Loading Units for Single Use, easyEndoTM Universal Linear Cutting Stapler and Loading Units for Single Use Ezisurg Medical Co., Ltd. GDW Class II 2017-12-21
K173349 Operio Toul Meditech AB ORC Class II 2017-12-20
DEN170075 ContainOR Advanced Surgical Concepts, Ltd. PZQ Class II 2017-12-19
K171271 Polyform Synthetic Mesh Boston Scientific Corporation OTO Class II 2017-12-15
K173043 Holycon Synthetic Absorbable Sutures Nantong Holycon Medical Devices Co., Ltd. GAM Class II 2017-12-14
K173002 2940 nm Er:Yag Laser Handpiece Quanta System Spa GEX Class II 2017-12-13
K172445 RoyalGuard Surgical Gown, i600, Breathable Gri Medical & Electrical Technology Co., Ltd. FYA Class II 2017-12-08
K172302 InMode PLUS System Inmode MD , Ltd. PBX Class II 2017-12-08
K172714 LipiVage Genesis Biosystems, Inc. MUU Class II 2017-12-08
K172908 Q-Switched Nd:YAG Laser System Ami, Inc. GEX Class II 2017-12-07
K172561 Disposable Circular Stapler Changzhou Kangdi Medical Stapler Co., Ltd. GDW Class II 2017-12-05
K172529 Vivaer ARC Stylus Aerin Medical, Inc. GEI Class II 2017-12-05
K172819 LightWalker Laser System Family Fotona D.O.O. GEX Class II 2017-12-01
K173038 CuRAS Nd:YAG Laser Ilooda Co,., Ltd. GEX Class II 2017-12-01
K172769 CryOmega Flexx Cryoconcepts LP GEH Class II 2017-11-30
K172538 Disposable Linear Stapler, Disposable Linear Cutter Changzhou Kangdi Medical Stapler Co., Ltd. GDW Class II 2017-11-30
K172771 Epic Pro 940 Biolase, Inc. GEX Class II 2017-11-29
K172689 DESCRIBE PFD Patch Merz North America, Inc. PKO Class II 2017-11-29
K172111 Vevazz LED Vevazz, LLC OLI Class II 2017-11-22
K173037 Visual-ICE MRI Cryoblation Console, Visual-ICE MRI Junction Box Assembly, Visual-ICE MRI Mobile Connection Panel Galil Medical, Inc. GEH Class II 2017-11-21
K173112 LAP-iX Sejong Medical Co., Ltd. GEI Class II 2017-11-21
K173169 Rapid Family Sharplight Technologies, Ltd. GEX Class II 2017-11-20
K172580 ENSEAL X1 Tissue Sealer, Straight Jaw, 25 cm Shaft Length, ENSEAL X1 Tissue Sealer, Straight Jaw, 37 cm Shaft Length, ENSEAL X1 Tissue Sealer, Curved Jaw, 25 cm Shaft Length,ENSEAL X1 Tissue Sealer, Curved Jaw, 37 cm Shaft Length,ENSEAL X1 Tissue Sealer, Curved Jaw, 45 cm Shaft Length Ethicon Endo-Surgery, LLC GEI Class II 2017-11-20
K171589 AEON Endoscopic Stapler Lexington Medical, Inc. GDW Class II 2017-11-17
K173305 NeuroBlate System Monteris Medical, GEX Class II 2017-11-17
K172363 DEKA SMARTXIDE ULTRASPEED El.En Electronic Engineering Spa GEX Class II 2017-11-17
K172362 DEKA SMARTXIDE TOUCH El.En Electronic Engineering Spa GEX Class II 2017-11-17
K172535 Bipolar applicator CELON ProCurve V Olympus Winter & Ibe GmbH GEI Class II 2017-11-16
K172856 Reprocessed LigaSure Blunt Tip Laparoscopic Sealer/Divider Stryker Sustainability Solutions GEI Class II 2017-11-16
K172712 gentleheel Micro-Preemie, gentleheel Preemie, gentleheel Newborn, gentleheel Toddler Gri Medical & Electronic Technology Co., Ltd. FMK Class II 2017-11-06
K172639 PALLAS 308/311 Solid-State UV Laser System Laseroptek Co., Ltd. GEX Class II 2017-11-03
K172757 Valleylab FX8 Electrosurgical Platform Covidien, LLC GEI Class II 2017-11-02
K172373 Compound W Nitro-Freeze Medtech Products, Inc. GEH Class II 2017-11-02
K170767 Surgical Stainless Steel Suture, Stainless Steel Suture ETHICON, Inc. GAQ Class II 2017-11-01
K172144 CoolSculpting System Zeltiq Aesthetics OOK Class II 2017-11-01
K171767 Cianna Medical SAVI Scout Reflector and SAVI Scout System Cianna Medical, Inc. NEU Class II 2017-10-31
K163659 Crystal Vision I.C Medical, Inc. FYD Class II 2017-10-30
K172077 Cutera enlighten III Laser System Cutera, Inc. GEX Class II 2017-10-27
K172325 Rhapsody H-30 Holmium Laser System Cook Incorporated GEX Class II 2017-10-26
K172132 CleanCision Wound Retraction and Protection System Prescient Surgical, Inc. PQI Class II 2017-10-25
K172937 Colorado Therapeutics Xenograft Implant Colorado Therapeutics, LLC FTM Class II 2017-10-25
K173242 CanGaroo Envelope (small), CanGaroo Envelope (medium), CanGaroo Envelope (large), CanGaroo Envelope (extra large) Aziyo Biologics, Inc. FTM Class II 2017-10-25
K173031 AtriClip LAA Exclusion System with Preloaded PRO·V Clip AtriCure, Inc. FZP Class II 2017-10-25
K171001 Monosyn Quick Synthetic Absorbable Surgical Suture Aesculap, Inc. GAM Class II 2017-10-23
K172805 gi-4000 Electrosurgical Generator United States Endoscopy Group, Inc. GEI Class II 2017-10-23
K172881 NeuroBlate System Monteris Medical, GEX Class II 2017-10-20
K171987 Finessis Zero Flexylon Powder Free Sterile White Surgical Glove Lucenxia Prescience AG KGO Class I 2017-10-20
K171052 Ultimate Contour, Ultimate Contour Mini CAO Group, Inc. PBX Class II 2017-10-20
K172149 FILASILK - Natural Non-absorbable Silk Surgical Suture, FILAMIDE - Non Absorbable polyamide surgical Sutures, MERICRON XL - Non Absorbable Polyester Surgical Suture, FILAPROP - Non Absorbable Polypropylene surgical Suture M/s. Meril Endo Surgery Private Limited. GAP Class II 2017-10-20
K172376 Discovery Pico, Discovery Pico Plus Quanta System Spa GEX Class II 2017-10-19
K172608 Medline ReNewal Reprocessed Stryker SERF AS Energy Probes Surgical Instrument Service and Savings, Inc. NUJ Class II 2017-10-18
K171752 X-SURGE Genicon, Inc. GEI Class II 2017-10-17
K172198 585 Quanta System Spa GEX Class II 2017-10-17
K172181 micro IPL El Global Trade, Ltd. OHT Class II 2017-10-13
K172023 CELFIRM VIOL Co., Ltd. GEI Class II 2017-10-13
K171702 Exciplex308nm Clarteis FTC Class II 2017-10-13
K171286 PAL Multi-Use Cannulas and PAL Manual Wand Microaire Surgical Instruments, LLC QPB Class II 2017-10-13
K171279 Sterile Nitrile Surgical Powder Free Gloves Tested for Use with Chemotherapy Drugs and Sterile Latex Surgical Powder Free Gloves Top Glove Sdn. Bhd. KGO Class I 2017-10-12
K172742 AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove Clip (PRO2) AtriCure, Inc. FZP Class II 2017-10-11
K171593 InMode RF System Inmode MD , Ltd. GEI Class II 2017-10-10
K172413 MT ONE M&T S.R.L. GEX Class II 2017-10-06
K172089 PROLENE Soft Polypropylene Mesh ETHICON, Inc. FTL Class II 2017-10-05
K172671 HelixAR Electrosurgical Generator with Argon Beam Coagulation, HelixAR Mobile Pedestal Conmed Corporation GEI Class II 2017-10-04
K172016 Force Fiber Fusion Suture Teleflex Medical Incorporated GAT Class II 2017-10-03
K170054 iSurg Jaco, LLC Dba Macan Manufacturing and Bna Burz North America GEI Class II 2017-10-02
K170505 SecurePortIV Catheter Securement Adhesive Adhezion Biomedical, LLC NZP Class II 2017-09-29
K170166 CARESORB-Polyglactin 910 Surgical Suture, CARESORB-Polyglactin 910 (fast absorbing) Surgical Suture Cpt Sutures Co., Ltd. GAM Class II 2017-09-29
K172420 Sterile Powder Free Nitrile Surgical Glove, White Colored. Tested for Use with Chemotherapy Drugs, with Non-Pyrogenic Labeling Claim Wear Safe (Malaysia) Sdn. Bhd. KGO Class I 2017-09-29
K172659 MEGASORB - Natural absorbable Polyglycolic Acid Surgical Suture, MITSU - Absorbable Polyglactin 910 Surgical Sutures, MITSU FST - Absorbable Polyglactin 910 Surgical Suture, FILAXYN - Absorbable Polydioxanone Surgical (PDS), FILAPRON - Absorbable poly(glycolide-co-caprolactone) Surgical Suture M/s. Meril Endo Surgery Private Limited. GAM Class II 2017-09-28
K161434 Photon Vibrating massage Facial Aesthetic Device (Model: UI-200) Li-Tek Electronics Technologies OLP Class II 2017-09-28
K163442 Single Use Micro Electrode (Brass with gold plated shaft); Single Use Micro Electrode (Stainless Steel shaft) Modern Medical Equipment Manufacturing Limited GEI Class II 2017-09-28
K163455 SurgiCube Surgicube International B.V. ORC Class II 2017-09-28
K170810 CRYOFOS Cryofos Medical GmbH GEH Class II 2017-09-27
K171992 SculpSure Cynosure, Inc. PKT Class II 2017-09-26
K171442 Exofin Fusion Skin Closure System Chemence Medical, Inc. OMD Class II 2017-09-25
K172545 SERI Contour Sofregen Medical, Inc. OXF Class II 2017-09-22
K171986 Sterling Supreme Diode Laser CAO Group, Inc. GEX Class II 2017-09-22
K171499 Occlusion Detection Dressing Kit Cardinalhealth OMP Class II 2017-09-22
K170758 Thermage FLX System and Accessories Solta Medical GEI Class II 2017-09-22
K171262 TempSure Cynosure, Inc. GEI Class II 2017-09-22
K172521 PICO Single Use Negative Pressure Wound Therapy System Smith & Nephew Medical Limited OMP Class II 2017-09-20
K170179 LightSheer Desire; LightSheer Desire Light; LightSheer Duet; LightSheer Infinity Lumenis, Ltd. GEX Class II 2017-09-18
K162828 Winback Back 3SE Winback USA Corp PBX Class II 2017-09-18
K172519 PICO Single Use Negative Pressure Wound Therapy System Smith & Nephew Medical Limited OMP Class II 2017-09-15
K163556 MediClear PreOp Covalontechnologies, Inc. KKX Class II 2017-09-14
K172481 IntelliCart System Dornoch Medical Systems JCX Class II 2017-09-14
K172479 Amsel Occluder Device Amsel Medical FZP Class II 2017-09-14

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