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General, Plastic Surgery

16,262 FDA 510(k) clearances · Medical specialty

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RecordFirmDate
Disposable Neutral Electrodes (GP201B-A, GP202B-A, GP202B-P, GP202B-I, GP202M-A, GP202M-P, GP202M-I, GP202B-AC, GP202B-PC, GP202B-IC, GP202M-AC, GP202M-PC, GP202M-IC, GP203M-A, GP203B-A, GP203M-AC, GP203B-AC, GP203M-P, GP203B-P, GP203M-PC, GP203B-PC, GP203M-I, GP203B-I, GP203M-IC, GP203B-IC) (K242204)Dongguan Quanding Medical Supplies Co., Ltd.2024-09-25
Diode Laser Hair Removal System (K241860)Beijing Winkonlaser Technology Limited2024-09-25
MOLLI 2 System (K240042)Molli Surgical, Inc.2024-09-25
Celsio Flexible Cryocatheter System (K240776)Endocision Technologies, Inc.2024-09-24
IPL Hair Removal Device (BE932C, BE932D, BE932E) (K241834)Shenzhen Yang WO Electronic Co., Ltd.2024-09-23
MTONE EVO (MTONE EVO) (K240604)M&T S.R.L.2024-09-20
Microwave Ablation Antennas (K241825)Canyon Medical, Inc.2024-09-20
Liftendo; Liftendo 2.0 (K241771)Medical San Indústria DE Equipamentos Médicos Ltda.2024-09-16
OneMark (K241762)View Point Medical2024-09-16
Vitruvian Liposaber (K240188)Black & Black Surgical, Inc.2024-09-13
CoolSculpting Elite System (K233732)Zeltiq Aesthetics, Inc. (Acquired by Allergan Aesthetics2024-09-12
ProPel SG3™ Surgical Gown (K241214)Standard Textile Co., Inc.2024-09-10
Ice Cooling IPL Hair Removal Device (Y6S GR, Y6S GA,Y6S GT, Y6S JU, Y6S JM, Y6S MU, Y6S OG, Y6S CH,Y6S PN,Y6S NK, Y6S PG, Y6S TG, Y6S OE) (K241205)Shenzhen Ulike Smart Electronics Co., Ltd.2024-09-09
FoLix (K242349)Lumenis Be, Ltd.2024-09-09
COPRO 3 (K241672)Amt Engineering Co., Ltd.2024-09-06
Cold Sore Device (QPZ-03) (K241155)Shenzhen Nuon Medical Equipment Co., Ltd.2024-09-05
ProGear® Surgical Mask with Oxafence®, Model AV82030 (K231741)Prestige Ameritech2024-09-05
Litho 60; Litho 100; Litho 150 (K242251)Quanta System Spa2024-09-03
IPL Hair Removal Device (JM-843, JM-865, JM-638) (K241881)Shenzhen Junmei Technology Co., Ltd.2024-08-29
SkinPen Precision Elite System (K241400)Crown Aesthetics2024-08-29
Safety Lancet (K242316)Ningbo Medsun Medical Co., Ltd.2024-08-28
Isolator Synergy EnCapture Ablation System (EMH) (K234151)AtriCure, Inc.2024-08-27
FiAPC plus probes (K242044)Erbe Elektromedizin GmbH2024-08-26
PRIMED Surgical Masks and PRIMED Procedure Masks (K240286)Primed Medical Products, Inc.2024-08-26
SOLTIVE™ Laser System (SOLTIVE™ Pro SuperPulsed Laser, SOLTIVE™ Premium SuperPulsed Laser, SOLTIVE Laser Fibers, and Accessories) (K242191)Olympus Surgical Technologies America2024-08-23
Polyisoprene Surgical gloves (K240790)Suzhou Colour-Way New Material Co., Ltd.2024-08-23
LightWalker Laser System Family (K242202)Fotona D.O.O.2024-08-23
VERSA Negative Pressure Wound Therapy System (VCMPP-100) (K241061)Cork Medical2024-08-21
Fraxel® FTX Laser System (K242142)Solta Medical2024-08-21
MULA (K2-A1) (K240314)Guangzhou Ciellulu Photoelectric Technology Co., Ltd.2024-08-21
HYDROS Robotic System; HYDROS TRUS Probe; HYDROS Handpiece (K240200)Procept Biorobotics2024-08-20
MedtFine Safety Lancet (K241848)Ningbo Caremed Medical Products Co., Ltd.2024-08-20
Luna 4 plus (K241102)Foreo, Inc.2024-08-20
CUTIVA(TM) Topical Skin Adhesive (RM-1700); CUTIVA(TM) PLUS Skin Closure System (RM-1739) (K234114)Okapi Medical, LLC Dba Resivant Medical2024-08-20
Negative Pressure Wound Therapy Device (V-Move, V-Grand) (K241023)Med Way, Inc.2024-08-19
NPseal (20 and 25) (K241522)Guard Medical, Inc.2024-08-15
Medifun Safety Lancet ( MSL1 series) (K241750)Medifun Corporation2024-08-15
MICROLET®NEXT Lancet (K241810)Ascensia Diabetes Care U.S., Inc.2024-08-15
SUPER VELOCE (K241699)Ilooda Co,., Ltd.2024-08-13
Diode Laser Therapy Device (DF-DIODE LASER-S1) (K241547)Weifang Dragonfly Electronics Technology Co., Ltd.2024-08-13
Ultravision2™ IonPencil (K240868)Alesi Surgical Limited2024-08-12
Eneka Selectif (K241656)Termosalud2024-08-12
MEDIDIODE (K231950)Medicreations, LLC2024-08-09
HyperSuture All Blue Extension Line (K241376)Threadstone, LLC2024-08-09
Liposaver (K212969)Lhbiomed Co., Ltd.2024-08-07
PlumeSafe X5 Smoke Management System (K240127)Conmed Corporation2024-08-05
CellFX Percutaneous Electrode System (SYS3000); CellFX Percutaneous Electrode, 13G (CPE013); CellFX Percutaneous Electrode, 18G (CPE018) (K240782)Pulse Biosciences, Inc.2024-08-05
da Vinci E-200 Electrosurgical Generator (K241635)Intuitive Surgical2024-08-05
HybridTherm System (K240932)Erbe Elektromedizin GmbH2024-08-05
Da Vinci Monopolar and Bipolar Adapters (378896) (K241621)Intuitive Surgical2024-08-02
Diode Laser Hair Removal System (MBT-Diode Laser) (K241642)Beijing Mega Beauty Technology Co., Ltd.2024-08-02
GCI Surgical Gown (K233571)George Courey, Inc.2024-08-02
BioBrace® Reinforced Implant (K241906)Conmed Corporation2024-07-29
AtriClip FLEX-Mini LAA Exclusion System (ACHM) (K234125)AtriCure, Inc.2024-07-29
Medical surgical mask (K233723)Guangdong Kingfa Sci. & Tech.Co., Ltd.2024-07-29
Resolv Endoscopic Hemostat System (K234131)Hemostasis, LLC2024-07-26
NEXA™ NPWT System (K241515)Nexa Medical Limited2024-07-26
PMD Clean Redvolution (4005-moab-NA, 4005-moab-INT, 4005-pepper-NA, 4005-pepper-INT, 4005-cream-NA, 4005-cream-INT, 4005-twilight-NA , 4005-twilight-INT, 4005-grey-NA, 4005-grey- INT) (K241203)Dongguan Hunter Electronic Technology Co., Ltd.2024-07-25
C2 CryoBalloon Ablation System (C2 CryoBalloon Ablation System) (K240457)Pentax of America, Inc.2024-07-24
InMode RF System (K240780)InMode , Ltd.2024-07-24
Onycho Laser V (K241116)Terasysd&C, Inc.2024-07-22
IntelliBlate Microwave Ablation System Console (IB-CON); IntelliBlate Microwave Ablation System Mobile Cart (IB-CART); IntelliBlate Ximitry Probe Assembly, 13G x 15cm (IB-XPA-1315); IntelliBlate Ximitry Probe Assembly, 13G x 20cm (IB-XPA-1320); IntelliBlate Ximitry Probe Assembly, 13G x 27cm (IB-XPA-1327) (K240480)Varian Medical Systems, Inc.2024-07-19
SOLID CLIP™ Single Use Clip Applier (K221495)Medscope Biotech Co., Ltd.2024-07-18
FAQ™ (102) (K240616)Foreo, Inc.2024-07-15
RFG-01 (K240178)Zimmer Medizinsysteme GmbH2024-07-15
CM00622 LINC Skin Closure System (CM00622 LINC) (K233460)Connexicon Medical , Ltd.2024-07-15
CM005 Standard (CM005); CM004 Mini (CM004) (K233458)Connexicon Medical , Ltd.2024-07-15
Megadyne Patient Return Electrode Pad - Universal Dual (model 0846), Megadyne Patient Return Electrode Pad - Universal Plus (model 0847), Megadyne Patient Return Electrode Pad - Universal Dual Plus (model 0848) (K233644)Megadyne Medical Products, Inc.2024-07-12
Peters Surgical ADVANTIME Absorbable Suture (ADVANTIME) (K232372)Peters Surgical2024-07-12
Valleylab ™FT10 Energy Platform Software Version 5.0 (VLFT10GEN VLFT10FXGEN VLFT10LSGEN) (K241085)Covidien, LLC2024-07-12
Sterile single use tip cleaner (WK800-S10 , WK800-S20) (K241022)Wickimed (Huizhou) Medical Equipment Manufacturing Co.,Ltd2024-07-11
IPL Hair Removal Device (YT01,YT02,YT03,YT04) (K240016)Shenzhen Jianrong Biomedical Electronics Co., Ltd.2024-07-10
HydroMARK™ Plus Breast Biopsy Site Marker (Hummingbird Shape) (4010-02-15-T6) (K240527)Devicor Medical Products, Inc.2024-07-10
OW100S (K233937)Softwave/Trt, LLC2024-07-09
IPL Hair Removal Device (LS-T121, LS-T121A, LS-T121B, LS-T121C, LS-T130, LS-T130A, LST130B, LS-T133, LS-T135, LS-T136, LS-T137, LS-T134, LS-T138, LS-T139, LS-T140) (K241343)Shenzhen Lescolton Electrical Appliance Co., Ltd.2024-07-09
LED Light Therapy Device, ELIXIR MD™ (K241293)Yassen Wellness, LLC2024-07-08
Dermablate (K241600)Asclepion Laser Technologies GmbH2024-07-03
FLUIDSHIELD* 1 Fog-Free Procedure Mask with SO SOFT* Lining and SO SOFT* Earloops, White (41802); FLUIDSHIELD* 1 Fog-Free Procedure Mask with SO SOFT* Lining and SO SOFT* Earloops, White, Wrap Around Visor (41803); FLUIDSHIELD* 1 Surgical Mask with SO SOFT* Lining, White, (41805) (K232824)Owens & Minor (O&M) Halyard, Inc.2024-07-02
MagDI System (DEN240013)Gt Metabolic Solutions, Inc.2024-07-02
Valleylab™ SM Smoke Management Pencil with Edge™ Blade Electrode, 10’ (3m) (VSMP10); Valleylab™ SM Smoke Management Pencil with Edge™ Blade Electrode, 15’ (4.6m) (VSMP15); Valleylab™ SM Smoke Management Pencil with Edge™ Blade Electrode, 10’ (3m), Non-Sterile Bulk (VSMP10NSB); Valleylab™ SM Smoke Management Extended Nozzle (for use with 4” (100mm) electrode) (VSMEN4); Valleylab™ SM Smoke Management Extended Nozzle (for use with 6.5” (165mm) electrode) (VSMEN6) (K240572)Covidien, LLC2024-07-01
Profound Matrix (K240070)Candela Corporation2024-07-01
FLUIDSHIELD* 1 Procedure Mask with SO SOFT* Lining and SO SOFT* Earloops, Lavender (25868); FLUIDSHIELD* 1 FogFree Procedure Mask with SO SOFT* Lining and SO SOFT* Earloops, Lavender, Wrap Around Visor (41798) (K232777)Owens & Minor (O&M) Halyard, Inc.2024-07-01
Electric nasal aspirator (HTD2601US) (K241202)Hetaida Technology Co., Ltd.2024-07-01
BioHealx Anal Fistula Device (DEN240007)Signum Surgical Limited2024-07-01
Lavieen (K241406)Wontech Co., Ltd.2024-06-28
Magseed Pro Magnetic Marker System (K232865)Endomagnetics Ltd.,2024-06-28
XSense Cryoablation System with Cryoprobes (K240892)IceCure Medical , Ltd.2024-06-28
Intense pulsed light therapy apparatus (FDA01, FDA02, FDA03, FDA04S, FDA05S, FDA06, FDA06S, FDA07, FDA07S, FDA08, FDA09S, FDA10S) (K241120)Qiaocheng LI (Dongguan) Medical Instruments Co., Ltd.2024-06-24
SILKRO (K233123)Hironic Co., Ltd.2024-06-24
Picosecond Nd:YAG Laser (PICOCAREMAJESTY) (K241144)Wontech Co., Ltd.2024-06-24
MOTUS PRO Family (K241459)El.En S.P.A.2024-06-21
Ice Cooling IPL Hair Removal Device (UI07 BR, UI07 DB, UI07 BL, UI07 GP, UI07 PN, UI07 RE, UI07 WH, UI07 PW, UI20 BR, UI20 DB, UI20 BL, UI20GP, UI20 PN, UI20 RE, UI20 WH, UI20 PW) (K240649)Shenzhen Ulike Smart Electronics Co., Ltd.2024-06-21
Fluidshield* 1 Procedure Mask with SO SOFT* Lining and SO SOFT Earloops (25869); Fluidshield* 1 Surgical Mask with SO SOFT* Lining (28802) (K232807)Owens & Minor (O&M) Halyard, Inc.2024-06-21
IVYLASER Diode laser hair removal system (IVY-HR-Alloy) (K240611)Ivylaser (Beijing) Technology Co.,Ltd2024-06-20
Safety Lancet (XXXV) (K241627)Tianjin Huahong Technology Co., Ltd.2024-06-20
IPL Home Use Hair Removal Device (D-1199, D-T099, D-T018, D-T019, D-T003B, D-T003W, D-T018Y, D-T019Y, D-1196B, D-1196W, D-1196C, D-1196C1, D-T099K, D-T099KW, D-T012, D-T012W) (K240583)Shenzhen Beauty Every Moment Intelligent Electric Co., Ltd.2024-06-18
Medical Diode Laser (M2-GK) (K240747)Wuhan Pioon Technology Co., Ltd.2024-06-17
3DMax Light Mesh (K241250)Davol Inc., Subsidiary of C. R. Bard, Inc.2024-06-14
CanGaroo RM Antibacterial Envelope (K233991)Elutia, Inc.2024-06-14
VersaWrap (K240817)Alafair Biosciences, Inc.2024-06-14
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