Review Panel
General, Plastic Surgery FDA 510(k) Clearances & Devices
- Cleared Devices
- 16,323
- Product Codes (page)
- 39
- Latest Decision
- 2026-06-17
Clearances · page 2 of 164
| K-Number | Trade Name | Applicant / Manufacturer | Product Code | Class | Decision Date |
|---|---|---|---|---|---|
| K253634 | CoolSeal Generator® (CSL-200-90) | Hologic, Inc. | GEI | Class II | 2026-06-17 |
| K261570 | PICOSURE WORKSTATION | Cynosure, LLC | GEX | Class II | 2026-06-17 |
| K261833 | NEUROMARK System (NMK00301) | Neurent Medical , Ltd. | GEI | Class II | 2026-06-16 |
| K254025 | LED Neck Beauty Mask (ZLD-66A,ZLD-90E,ZLD-130,ZLD-180H) | Shenzhen Kaiyan Medical Equipment Co., Ltd. | OHS | Class II | 2026-06-16 |
| K252171 | Barbed PDO Suture | Sutura Medical Technology, Inc. | NEW | Class II | 2026-06-12 |
| K261634 | Disposable Blood Lancet (Soft) | SteriLance Medical (Suzhou), Inc. | QRK | Class II | 2026-06-12 |
| K261204 | Intense Pulsed Light Therapy Device | Sanhe LEFIS Electronics Co., Ltd. | ONF | Class II | 2026-06-12 |
| K260653 | Dexter L6 System | Distalmotion SA | SDD | Class II | 2026-06-11 |
| K261621 | TekBrace Solo Soft Tissue Reinforcement Device | Theramicro | QUW | Class II | 2026-06-09 |
| K253165 | LAP-iX2N | Sejong Medical Co., Ltd. | GEI | Class II | 2026-06-09 |
| K261806 | ERBECRYO 2 Cryosurgical Unit and Accessories | Erbe Elektromedizin GmbH | GEH | Class II | 2026-06-09 |
| K251944 | Lipocosm Harmonic System | Lipocosm, LLC | QPB | Class II | 2026-06-08 |
| K253656 | OsteoCool RF Ablation System; OsteoCool 2.0 RF Ablation System | Medtronic Sofamor Danek USA, Inc. | GEI | Class II | 2026-06-05 |
| K252575 | Tuff Cuff Disposable Surgical Gowns AAMI L4 Sterile-Large (ML-L4-STL-DC-L) | New York Embroidery Studio (NYES) | FYA | Class II | 2026-06-04 |
| K260690 | LumiGlam Laser System (SHE-LSP601-3) | Beijing Sano Laser S&T Development Co.,Ltd | GEX | Class II | 2026-06-04 |
| K253102 | GT Metabolic MagDI System (MAG-01, MAG-02, DS-01) | Gt Metabolic Solutions, Inc. | SAH | Class II | 2026-06-04 |
| K261484 | Tissue Approximation System | Tas Medical, Inc. | GAR | Class II | 2026-06-03 |
| K260715 | CurrentBody Skin LED Multi Light Therapy Mask (MK-110D) | The Beauty Tech Group, Ltd. | OHS | Class II | 2026-06-03 |
| K253918 | Veineo System (00MEDRF4000TCUS 05CR45iT 06Pedal1St) | F Care Systems USA, LLC | GEI | Class II | 2026-06-02 |
| K253302 | Hemospray Endoscopic Hemostat (HEMO-[X]) | Wilson-Cook Medical, Inc. | QAU | Class II | 2026-06-02 |
| K253803 | MILAN System | Lumenis Be, Ltd. | GEI | Class II | 2026-06-02 |
| K261541 | VisionAir Enhanced Stock Stent | VisionAir Solutions | NWA | Class II | 2026-06-01 |
| K260138 | LUNE PureHygiene | Enamel Pure | GEX | Class II | 2026-05-29 |
| K261202 | ENTire IRE System | Entire Medical , Ltd. | GEI | Class II | 2026-05-29 |
| K260489 | LASEmaR 1500 | Eufoton S.R.L. | GEX | Class II | 2026-05-29 |
| K253530 | Trexon Monofilament Synthetic Absorbable Suture | Medtronic | GAM | Class II | 2026-05-28 |
| K260646 | RENASYS EDGE (66803126) | Smith & Nephew Medical, Ltd. | OMP | Class II | 2026-05-27 |
| K253629 | Momcozy Nasal Aspirator (BN007) | Shenzhen Root Innovation Technology Co., Ltd. | BTA | Class II | 2026-05-26 |
| K252833 | VIVA combo RF System | Starmed Co., Ltd. | GEI | Class II | 2026-05-26 |
| K253060 | Sterile Latex Powder Free Surgical Gloves | Protect Gloves Company Limited | KGO | Class I | 2026-05-22 |
| K252917 | ATLAAS (Atraumatic Left Atrial Appendage System) (AD) | Genesee Biomedical, Inc. | PZX | Class II | 2026-05-22 |
| K261325 | Ice Cooling IPL Hair Removal Device (UI06S PR, UI06S PN, UI06S WH, UI06S PRU, UI06S PNU, UI06S WHU) | Shenzhen Ulike Smart Electronics Co., Ltd. | OHT | Class II | 2026-05-21 |
| K253956 | ProGrip advanced self-gripping polypropylene mesh (ADG1510, ADG2015, ADG3020, ADG4030) | Sofradim Production | FTL | Class II | 2026-05-21 |
| K261291 | Nisus NPWT Canister 500-mL (CPC-500) | Cork Medical | OMP | Class II | 2026-05-21 |
| DEN250028 | DeepView AI® System | Spectralmd, Inc. | SHY | Class II | 2026-05-21 |
| K253245 | Boston 2910 (Boston 2910) | Boston Aesthetics, Inc. | GEX | Class II | 2026-05-21 |
| K260618 | Ulthera® System | Ulthera, Inc. | OHV | Class II | 2026-05-21 |
| K260594 | IPL Hair Removal Device (FL-B505AG, FL-B505AP, FL-B505AM, FL-B507AG, FL-B507AP, FL-B507AM, FL-B508AG, FL-B508AP, FL-B508AM, FL-B509AG, FL-B509AP, FL-B509AM, FL-B510G, FL-B510P, FL-B510M, FL-B511G, FL-B511P, FL-B511M, FL-B512AG, FL-B512AP, FL-B512AM, FL-B513AG, FL-B513AP, FL-B513AM) | Shenzhen Xiazhifeng Electronic Co., Ltd. | OHT | Class II | 2026-05-20 |
| K253134 | LAGIS Endoscopic Instruments- Scissors (EI-330S EI-330S-T EI-330MS EI-330MS-T) | Lagis Enterprise Co., Ltd. | GEI | Class II | 2026-05-20 |
| K253309 | SOGA Lasers therapy system family of Aurora handpiece (Aurora-S); SOGA Lasers therapy system family of the Dental diode laser ( ILaser III Pro) | Shenzhen Soga Technology Co., Ltd. | NVK | Class II | 2026-05-19 |
| K260522 | RhinAer+ Stylus | Aerin Medical, Inc. | GEI | Class II | 2026-05-18 |
| K260100 | MOSES Raydar | Boston Scientific Corporation | GEX | Class II | 2026-05-18 |
| K252047 | STRATAFIX Symmetric PDS Plus Knotless Tissue Control Devices | ETHICON, Inc. | NEW | Class II | 2026-05-18 |
| K260134 | Baby Nasal Aspirator (BN006, BN006-A, BN006-B, BN006-C, BN006-D, BN02; BN008, BN008-A, BN008-B, BN008-C, BN008-D, BC-021) | Shenzhen Root Innovation Technology Co., Ltd. | BTA | Class II | 2026-05-15 |
| K260892 | Suction Pump (SU-90) | Shenzhen HugeMed Medical Technical Development Co., Ltd. | BTA | Class II | 2026-05-14 |
| K252591 | Automatic Micro Needle System (CODE-X) | Woorhi Mechatronics Co., Ltd. | QAI | Class II | 2026-05-13 |
| K260415 | myLEDmask 2 (MJ-144) | Light Tree Ventures Europe B.V. | OHS | Class II | 2026-05-12 |
| K260473 | Electric nasal aspirator (BC027, BC030, BC033, BC035, BC035B) | Shenzhen Kingboom Technology Co., Ltd. | BTA | Class II | 2026-05-12 |
| K260725 | BAÜMER Surgical Gowns (COP01, COP04, COP05, COP10) | Hindernis DE Mexico, S.A.P.I. DE C.V. | FYA | Class II | 2026-05-12 |
| K260196 | ETHICON Circular Stapler (CDH21mm); ETHICON Circular Stapler (CDH25mm); ETHICON Circular Stapler (CDH29mm); ETHICON Circular Stapler (CDH33mm); ETHICON Circular Stapler - XL Sealed (ECS21mm); ETHICON Circular Stapler - XL Sealed (ECS25mm); ETHICON Circular Stapler - XL Sealed (ECS29mm); ETHICON Circular Stapler - XL Sealed (ECS33mm) | Ethicon Endo-Surgery, LLC | GDW | Class II | 2026-05-11 |
| K261214 | PICO SHINING (PICO-K; PICOFY) | Speclipse, Inc. | GEX | Class II | 2026-05-11 |
| K250964 | Protable Phlegm Suction Unit (JMA D01) | Jiangsu Jumao X-Care Medical Equipment Co., Ltd. | JCX | Class II | 2026-05-11 |
| K253396 | AYON Body Contouring System (AYON SYSTEM) | Apyx Medical Corporation | QPB | Class II | 2026-05-08 |
| K260974 | CO2 Laser Machine (Monica-I,Monica-II) | Nanjing Bestview Laser S&T Co., Ltd. | GEX | Class II | 2026-05-07 |
| K253826 | Aliya® EX System; Aliya® EX Generator; Aliya® Needle; Aliya® Electrode; INUMI Flex Needle | Galvanize Therapeutics, Inc. | OAB | Class II | 2026-05-07 |
| K260775 | Polyethylene;Polyethylene Fusion;Polyethylene OrthoTape | Teleflex Medical, LLC | GAT | Class II | 2026-05-06 |
| K260742 | Ice Cooling IPL Hair Removal Device (UI20S DB, UI20S RE, UI20S PW, UI20S GP, UI20S GR, UI20S BK) | Shenzhen Ulike Smart Electronics Co., Ltd. | OHT | Class II | 2026-05-05 |
| K260256 | Q-Switched Nd: YAG Laser Systems | Shanghai Apolo Medical Technology Co., Ltd. | GEX | Class II | 2026-05-04 |
| K254019 | Wound Geni NPWT System | Bechtel Medical, Inc. | OMP | Class II | 2026-05-04 |
| K260688 | Sculpt LED Belt (HY-150A/HY-150B/HY-200A/HY-200B/HY-420A/HY-200D/HY-200C) | Shenzhen Kaiyan Medical Equipment Co., Ltd. | OLI | Class II | 2026-05-04 |
| K253251 | Leaseir MHR Xcell (console) (MHR-100b); Handpiece: Dual (810-b and Blend-b); Handpiece: Quad (810-b and Blend-b) | Leaseir Technologies, Slu | GEX | Class II | 2026-05-04 |
| K261045 | Verifine Safety Lancets | Promisemed Hangzhou Meditech Co., Ltd. | FMK | Class II | 2026-05-01 |
| K254234 | Phototherapy System (DUV-COMBO) | Choyang Medics Co., Ltd. | FTC | Class II | 2026-05-01 |
| K261094 | YellowStar | Asclepion Laser Technologies GmbH | GEX | Class II | 2026-04-29 |
| K253243 | Cardinal Health Poly Reinforced Surgical Gown | Cardinal Health 200, LLC | FYA | Class II | 2026-04-28 |
| K260982 | Alexis lighted wound protector-retractor, flexible, extra small (cl312);Alexis lighted wound protector-retractor, flexible, small (cl301);Alexis lighted wound protector-retractor, flexible, medium (cl302);Alexis lighted wound protector-retractor, flexible, large (cl303);Alexis lighted wound protector-retractor, rigid, small (cl401);Alexis lighted wound protector-retractor, rigid, medium (cl402); Alexis lighted wound protector-retractor, rigid, large (cl403) | Applied Medical Resources Corporation | KGW | Class II | 2026-04-24 |
| K260976 | NeuroBlate System | Monteris Medical | ONO | Class II | 2026-04-23 |
| K260150 | LED FACIAL MASK (MJ-66DB, MK-99, MK-99A, MK-99M, MJ-66C) | NOOANCE | OHS | Class II | 2026-04-22 |
| K253765 | VANISH PRO | Ddc Technologies, Inc. | GEX | Class II | 2026-04-22 |
| K253230 | ERBECRYO 2 Cryosurgical Unit and Accessories: ERBECRYO 2 cryosurgical unit; Erbe Flexible Cryoprobe | Erbe Elektromedizin GmbH | GEH | Class II | 2026-04-22 |
| K260518 | IPL Hair Removal (SL-B301, SL-B300, SL-B330, SL-B330-1, SL-B287-1, SL-B371, SL-B371-2, SL-B371-1, SL-B352, SL-B352-1, SL-B352-2, SL-B330-F) | Shenzhen Semlamp Intelligent Technology Co., Ltd. | OHT | Class II | 2026-04-21 |
| K260153 | Q-Switched Nd: YAG Laser System (Glamor Q) | Nanjing Bestview Laser S&T Co., Ltd. | GEX | Class II | 2026-04-20 |
| K253003 | Non-sterile Level 3 Surgical Gown (4025); Sterile Level 3 Surgical Gown (M4025); Non-sterile Reinforced Level 4 Surgical Gown (G4025); Reinforced Sterile Level 4 Surgical Gown (GM4025) | Hubei Xinxin Non-Woven Co., Ltd. | FYA | Class II | 2026-04-20 |
| K260307 | Diode Laser Therapy Systems (V19) | Weifang Mingliang Electronics Co., Ltd. | GEX | Class II | 2026-04-15 |
| K260129 | Lumaflex Panel (ZLD-05, ZLD-05A, ZLD-05APro ) | Shenzhen Kaiyan Medical Equipment Co., Ltd. | OLI | Class II | 2026-04-15 |
| K253107 | Electric Nasal Aspirator (DT10 and DT50, DX80, DX85, DX86 and DX90) | Shenzhen Dongjiang Technology Co., Ltd. | BTA | Class II | 2026-04-14 |
| K253777 | Ascblue (8010) | Ascblue Corporation | GEI | Class II | 2026-04-10 |
| K253657 | Tri-staple 2.0 Reloads; Endo GIA Reloads with Tri-Staple Technology; Endo GIA Gray Articulating Reloads; Signia Small Diameter Reloads | Covidien (Part of Medtronic) | GDW | Class II | 2026-04-10 |
| K253917 | ARION ARC System | Plasma Surgical, Inc. | GEI | Class II | 2026-04-10 |
| K260317 | Artelon Convenience Kits | International Life Sciences | QWJ | Class II | 2026-04-09 |
| K260017 | Picosecond Nd:YAG Laser Systems (Model: HS-298) | Shanghai Apolo Medical Technology Co., Ltd. | GEX | Class II | 2026-04-09 |
| K260466 | Multifunctional Operational Dissectors (Electrosurgical Pencils);Multifunctional Operational Dissectors (Disposable Electrode) | Zhejiang shuyou Surgical Instrument Co., Ltd. | GEI | Class II | 2026-04-07 |
| K260397 | SYNERJET PRO (SP-1002); InPhiuse (SP-1002); WOWJET (SP-1002) | Hironic Co., Ltd. | GEI | Class II | 2026-04-06 |
| K252495 | LSSA (NP-200) | Newpong Co., Ltd. | QPB | Class II | 2026-04-03 |
| K260647 | SPECCHIO | El.En S.P.A. | PBX | Class II | 2026-04-02 |
| K252198 | Advanced Cryo Skin Tag Remover (Advanced Skin Tag Remover) | Medical Brands Laboratories B.V. | GEH | Class II | 2026-04-02 |
| K253405 | Prana System | Prana Surgical | GEI | Class II | 2026-04-01 |
| K260375 | Nd: YAG Laser Therapy Systems | Sanhe Meditech Co., Ltd. | GEX | Class II | 2026-03-31 |
| K260191 | Safety lancet (XXXVII) | Tianjin Huahong Technology Co., Ltd. | FMK | Class II | 2026-03-31 |
| K254122 | FLOW FLEXTEND Wand (72290039) | ArthroCare Corporation | GEI | Class II | 2026-03-30 |
| K260257 | CO2 Laser System | Sanhe Meditech Co., Ltd. | GEX | Class II | 2026-03-28 |
| K260255 | AVENTIX PFX System (PFX01); NOVOCLEAR Device (CLR001) | Aventix Medical, Inc. | GEI | Class II | 2026-03-27 |
| K253572 | STRATAFIX Spiral PRONOVA Unidirectional Knotless Tissue Control Device STRATAFIX Spiral PRONOVA Bidirectional Knotless Tissue Control Device | ETHICON, Inc. | GAW | Class II | 2026-03-27 |
| K253680 | LYNX COBLATION Laryngeal Wand (72290254) | ArthroCare Corporation | GEI | Class II | 2026-03-25 |
| K253198 | NanoKnife Generator (H78720300351US0) | Angiodynamics | OAB | Class II | 2026-03-24 |
| K254275 | HyperSuture All Green Extension Line | Threadstone, LLC | GAT | Class II | 2026-03-23 |
| K260202 | LED Light Therapy Masks (LumiLips FAC07NA) | Guangdong Newdermo Biotech Co., Ltd. | OHS | Class II | 2026-03-23 |
| K251967 | HALYARD* FLUIDSHIELD* 3 Fog-Free Procedure Mask with SO SOFT* Lining and SO SOFT* Earloops; HALYARD* FLUIDSHIELD* 3 Fog-Free Procedure Mask with SO SOFT* Lining and SO SOFT* Earloops with WrapAround Visor | O&M Halyard, Inc. | FXX | Class II | 2026-03-18 |
| K260632 | LASER THERMAL THERAPY KIT | Elesta S.P.A | GEX | Class II | 2026-03-17 |
| K252971 | Elyra Thulium Fiber Laser System and Elyra Plus Thulium Fiber Laser System (Laser, Fibers, and Accessories) | C.R. Bard, Inc. | GEX | Class II | 2026-03-17 |
16,323 clearances in the General, Plastic Surgery panel. Data: openFDA.