Review Panel
General, Plastic Surgery FDA 510(k) Clearances & Devices
- Cleared Devices
- 16,323
- Product Codes (page)
- 41
- Latest Decision
- 2024-02-01
Clearances · page 11 of 164
| K-Number | Trade Name | Applicant / Manufacturer | Product Code | Class | Decision Date |
|---|---|---|---|---|---|
| K233183 | Surgical Gown (40083) | Ammex-Weida (Hubei) Health and Safety Products Co., Ltd. | FYA | Class II | 2024-02-01 |
| K233804 | Resonic Rapid Acoustic Pulse Device | Zeltiq Aesthetics, Inc. | GEX | Class II | 2024-02-01 |
| K233140 | Microwave Ablation Device (Exceed S10U); Sterile Microwave Ablation Probe (Exact) | Hygea Medical Technology Co., Ltd. | NEY | Class II | 2024-01-31 |
| K234140 | VIVA combo RF System (VIVA combo RF System) | Starmed Co., Ltd. | GEI | Class II | 2024-01-30 |
| K231910 | DermRays Revive | Wuhan Lotuxs Technology Co., Ltd. | GEX | Class II | 2024-01-30 |
| K233224 | Epilaser Pro | Epilady 2000, LLC | GEX | Class II | 2024-01-27 |
| K232912 | Facet Aurora Reusable Lancet Base | Facet Technologies, LLC | QRL | Class II | 2024-01-25 |
| K233425 | FlexTip Bipolar electrodes single-use (AR-S9805-0028), FlexTip Bipolar electrodes single-use (AR-S9805-0035) | Sutter Medizintechnik GmbH | GEI | Class II | 2024-01-25 |
| K230836 | SchurSign Tissue Marker | Surgmark GmbH | NEU | Class II | 2024-01-23 |
| K233887 | IPL Hair Removal Device (UI06PN, UI06 PL, UI06 JL, UI06 BR, UI06 DB, UI06 PR, UI06 OG, UI06 RD, UI08 BR, UI08 DB, UI08 BL, UI08 GP, UI08 PN, UI08 RE, UI08 WH, UI08 PW, UI07 BR, UI07 DB, UI07 BL, UI07 GP, UI07 PN, UI07 RE, UI07 WH, UI07 PW, UI20 BR, UI20 DB, UI20 BL, UI20 GP, UI20 PN, UI20 RE, UI20 WH, UI20 PW) | Shenzhen Ulike Smart Electronics Co., Ltd. | OHT | Class II | 2024-01-22 |
| K231405 | Sterile Single Use Electrosurgical Pencil with Non-Coated Electrode, Sterile Single Use Electrosurgical Pencil with Non-Stick Electrode | Jiangsu Rong FU Kang Medical Instruments Co., Ltd. | GEI | Class II | 2024-01-18 |
| K233077 | FlashHeal 2 (FlashHeal 2.0) | Inwound Aps | GEX | Class II | 2024-01-18 |
| K232373 | Progrip Self-Gripping Polypropylene Mesh | Sofradim Production | FTL | Class II | 2024-01-18 |
| K232355 | Non absorbable Surgical Silk Suture | Shandong Haidike Medical Product Co., Ltd. | GAP | Class II | 2024-01-16 |
| K223266 | Hilzo Esophageal Stents | Thoracent, Inc. | ESW | Class II | 2024-01-16 |
| K233796 | Disposable safety lancet (Impress); Disposable safety lancet (Impress Pro); Disposable safety lancet (Lite4); Disposable blood lancet (Elite); Disposable blood lancet (Elite Pro) | SteriLance Medical (Suzhou), Inc. | FMK | Class II | 2024-01-16 |
| K233355 | Cypris eXact Suturing System | Cypris Medical | GAW | Class II | 2024-01-12 |
| K232970 | Hem-o-lok® Ligating Clips | Teleflex Medical | FZP | Class II | 2024-01-12 |
| DEN230008 | DermaSensor | Dermasensor, Inc. | QZS | Class II | 2024-01-12 |
| K233022 | Halyard Fluidshield 3 N95 Particulate Filter Respirator and Surgical Mask with So Soft Lining, Orange, Regular and Small, Halyard Fluidshield 3 N95 Particulate Filter Respirator and Surgical Mask with Safety Seal and So Soft Lining, Orange, Regular and Small, Halyard Fluidshield 2 N95 Particulate Filter Respirator and Surgical Mask with So Soft Lining, White, Regular and Small | Owens & Minor (O&M) Halyard, Inc. | MSH | Class II | 2024-01-12 |
| K232615 | LumiMARK Biopsy Site Marker (LM0215T (Tulip Shape)); LumiMARK Biopsy Site Marker (LM0215L (Lotus Shape)); LumiMARK Biopsy Site Marker (LM0215R (Rose shape)) | Devicor Medical Products, Inc. | NEU | Class II | 2024-01-12 |
| K233114 | LED silicone mask (Model: LP-RVTGLWP-WHT, LP-RVTGLW-WHT, TLM200) | Shenzhen Idea Light Limited | OHS | Class II | 2024-01-12 |
| K233664 | IPL Hair Removal Device (UI06 PN, UI06 PL, UI06 JL, UI06 BR, UI06 DB, UI06 PR, UI06 OG, UI06 RD,UI06 WH, UI06 MG, UI06 OB, UI06 LY,UI06 IG,) | Shenzhen Ulike Smart Electronics Co., Ltd. | OHT | Class II | 2024-01-11 |
| K233615 | Electrosurgical Pads (GBS-Dm 1030ac, GBS-Db 1031ac, GBS-Dm 1030a, GBS-Db 1031a, GBS-Dm 1130ac, GBS-Db 1131ac, GBS-Dm 1130a, GBS-Db 1131a, GBS-Dm 1040ac, GBS-Db 1041ac, GBS-Dm 1040a, GBS-Db 1041a, GBS-Dm 1140ac, GBS-Db 1141ac, GBS-Dm 1140a, GBS-Db 1141a, GBS-Db 4030c, GBS-Db 4030, GBS-Db 4040c, GBS-Db 4040, GBS-Dm 1030bc, GBS-Db 1031bc, GBS-Dm 1030b, GBS-Db 1031b, GBS-Dm 1130bc, GBS-Db 1131bc, GBS-Dm 1130b, GBS-Db 1131b, GBS-Dm 1030nc, GBS-Db 1031nc, GBS-Dm 1030n, GBS-Db 1031n, GBS-Dm 1 | Baisheng Medical Co., Ltd. | GEI | Class II | 2024-01-08 |
| K232894 | HALYARD* FLUIDSHIELD* 2 Surgical Mask with Expanded Chamber with SO SOFT* Lining (39123), HALYARD* FLUIDSHIELD* 2 Surgical Mask with Expanded Chamber with SO SOFT* Lining and Visor (39124) | Owens & Minor (O&M) Halyard, Inc. | FXX | Class II | 2024-01-08 |
| K232106 | Air Gap Fiber | Wontech Co., Ltd. | GEX | Class II | 2024-01-08 |
| K231163 | HS Fiber Sutures | Riverpoint Medical | GAT | Class II | 2024-01-05 |
| K233679 | IPL Hair Removal Device (UI04 MK,UI04 BN,UI04 BU,UI04 CB,UI04 GY,UI04 LG,UI04 DG,UI04 PL,UI04 PN,UI04 SD,UI04 SG,UI04 MG) | Shenzhen Ulike Smart Electronics Co., Ltd. | OHT | Class II | 2024-01-05 |
| K221766 | Solon | Lmg Lasers Comercio, Importacao E Exportacao Ltda | GEX | Class II | 2024-01-05 |
| K233556 | LED Eye mask (EY-20R, A20, EY-20N) | Shenzhen Kaiyan Medical Equipment Co., Ltd. | OHS | Class II | 2024-01-04 |
| K232330 | Lancing System | Ningbo Medsun Medical Co., Ltd. | QRK | Class II | 2024-01-04 |
| K233550 | MOSAIC 3D (Surgical Laser) | Lutronic Aesthetic | ONG | Class II | 2024-01-02 |
| K232789 | VIO System (V-1000) | Enspectra Health, Inc. | QZN | Class II | 2023-12-22 |
| K233104 | SofWave System | Sofwave Medical, Ltd. | OHV | Class II | 2023-12-22 |
| K233304 | Omnimax S3, Omnimax S4 | Sharplight Technologies, Ltd. | GEX | Class II | 2023-12-22 |
| K233018 | PICOSECOND Nd:YAG Laser System | Ids, Ltd. | GEX | Class II | 2023-12-21 |
| K221753 | Kangbeier Child Surgical Mask | Xinxiang Kangbeier Medical Technology Co., Ltd. | OXZ | Class II | 2023-12-21 |
| K232444 | Sterile Powder Free Latex Surgical Gloves, Tested for Use with Chemotherapy Drugs | Grand Work Plastic Products Co., Ltd. | KGO | Class I | 2023-12-20 |
| K233782 | SmoothSkin Pure Adapt (SSG3) | Cyden Limited | OHT | Class II | 2023-12-20 |
| K232992 | 10THERMA | Tentech, Inc. | GEI | Class II | 2023-12-20 |
| K233237 | xeo+ Family | Cutera, Inc. | GEX | Class II | 2023-12-15 |
| K232939 | IPL Hair Removal Device | Shenzhen Borria Technology Co., Ltd. | OHT | Class II | 2023-12-15 |
| K233564 | FLUOBEAM® LX Imaging System (FB-LX); FLUOBEAM® LX Red Imaging System (FB-LXR) | Fluoptics Sas (A Getinge Group Company) | QDG | Class II | 2023-12-15 |
| K233374 | Secret Pro | Ilooda Co,., Ltd. | GEI | Class II | 2023-12-14 |
| K232455 | SofWave System | Sofwave Medical, Ltd. | OHV | Class II | 2023-12-14 |
| K232863 | Radiant Renewal Skincare Wand (HD-15, HD-15A) | Shenzhen Kaiyan Medical Equipment Co., Ltd. | OHS | Class II | 2023-12-13 |
| K233811 | DT Controlled Phototherapy Equipment | Daavlin Distributing Co. | FTC | Class II | 2023-12-13 |
| K232947 | SIRA RFA Electrosurgical Device | Innoblative Designs, Inc. | GEI | Class II | 2023-12-12 |
| K232797 | Hygenix | Shenzhen Hygenix Industrial Co., Ltd. | FXX | Class II | 2023-12-11 |
| K232290 | INTELLIO SHIFT System | ArthroCare Corporation | GEI | Class II | 2023-12-11 |
| K231061 | NeuroBlate System | Monteris Medical, | GEX | Class II | 2023-12-08 |
| K232795 | Led Mask Platinum Exclusive MD | Stg24 Co., Ltd. | OHS | Class II | 2023-12-07 |
| K232846 | Light Based Hair Removal Device | Shenzhen Meik Beauty Industry Co., Ltd. | OHT | Class II | 2023-12-07 |
| K230677 | Cork Medical VERSA Negative Pressure Wound System (VCMPP-100) | Cork Medical | OMP | Class II | 2023-12-06 |
| K230712 | SG Lanset I, SG Lancets, Soft Lancets | Sewon Medical Co. | QRK | Class II | 2023-12-06 |
| K232769 | BeaMed Laser Surgery Fibers | Bt Beamedical Tachnoogies Ltd. (Beamed) | GEX | Class II | 2023-12-06 |
| K230734 | Multispectral Imager Kit (MSI Kit) (300-00015), Multispectral Imager (MSI) (300-00009) | Precision Healing, LLC | QJF | Class II | 2023-12-05 |
| K231615 | Disposable Endoscopic Bipolar | Jiangsu Hope Biomedical Science & Technology Co., Ltd. | GEI | Class II | 2023-12-05 |
| K231005 | Aurelia Surgical Mask ASTM Level 1; Aurelia Surgical Mask ASTM Level 2 | Supermax Healthcare Canada-Supermax Medical | FXX | Class II | 2023-12-05 |
| K233347 | Verruca-Freeze® H | Cryosurgery, Inc. | GEH | Class II | 2023-12-04 |
| K232932 | Intense Pulse Light Therapeutic Apparatus | Shenzhen Greatro Electronic Technology Co., Ltd. | OHT | Class II | 2023-12-04 |
| K232708 | Intense pulsed light therapy device | Hebei Zhemai Technology Co., Ltd. | ONF | Class II | 2023-12-01 |
| K233301 | ULTRApulse Alpha CO2 Laser System, Delivery Devices and Accessories | Lumenis Be, Ltd. | GEX | Class II | 2023-12-01 |
| K230621 | LaproGlide Disposable Monopolar PTFE Coated Laparoscopic Probes | Surgical Principals, Inc. | GEI | Class II | 2023-12-01 |
| K232709 | Diode laser therapy device | Hebei Zhemai Technology Co., Ltd. | GEX | Class II | 2023-11-30 |
| K232716 | Q-Switched Nd:Yag laser | Hebei Zhemai Technology Co., Ltd. | GEX | Class II | 2023-11-30 |
| K232033 | HYBRIDknife® flex | Erbe Elektromedizin GmbH | GEI | Class II | 2023-11-29 |
| K232117 | Diode Laser Hair Removal (LHR-V6S-1064, LHR-V6S/B-1064) | Wuhan Lotuxs Technology Co., Ltd. | GEX | Class II | 2023-11-28 |
| K233493 | Tricera Arthroscopic System; Tricera Controller (R-10001); Tricera Shaver Handpiece (R-10023); Veriflow (R-10003); Exoflow (R-10017); 3-in-1 Shaver 4.2mm (R-10008); 3-in-1 Shaver 5.0mm (R-10014); Dynablator (R-10005); Standard Burr (R-10021); Standard Shaver 3.4mm (R-10012); Curved Standard Shaver 3.4mm (R-10024) | Relign Corporation | GEI | Class II | 2023-11-28 |
| K232222 | Primo Dental Laser (Primo, Primo Komfort, Primo Lite, Primo Blue, and Primo Triplo) | Medency S.R.L. | NVK | Class II | 2023-11-27 |
| K231661 | CryoThin Surgical System and Accessories | Medinux (Tianjin) Technologies Co., Ltd. | GEH | Class II | 2023-11-27 |
| K230311 | HyperSuture | Threadstone, LLC | GAT | Class II | 2023-11-24 |
| K232635 | IceSeed 1.5 CX 90º Needle (H7493967433170); IceSeed 1.5 CX S 90º Needle (H7493967233100) | Boston Scientific | GEH | Class II | 2023-11-22 |
| K231797 | Medifun Lancing Device, Model No. LD-E1 | Medifun Corporation | QRL | Class II | 2023-11-22 |
| K232593 | FITme Customized Silicone Implant | Keosan Trading Co. | FWP | Class II | 2023-11-22 |
| K232977 | Biophotas Celluma CONTOUR | Biophotas, Inc. | OLI | Class II | 2023-11-21 |
| K233346 | Heinrich Single Use Non-Stick Bayonet Bipolar Forceps, 180mm, 0.5mm Tip with Cable (HMAL18/005); Heinrich Single Use Non-Stick Bayonet Bipolar Forceps, 180mm, 1.0mm Tip with Cable (HMAL18/010); Heinrich Single Use Non-Stick Bayonet Bipolar Forceps, 180mm, 1.5mm Tip with Cable (HMAL18/015); Heinrich Single Use Non-Stick Bayonet Bipolar Forceps, 200mm, 0.5mm Tip with Cable (HMAL20/005); Heinrich Single Use Non-Stick Bayonet Bipolar Forceps, 200mm, 1.0mm Tip with Cable (HMAL20/010); | Hg Innovations, Ltd. | GEI | Class II | 2023-11-20 |
| K233351 | Single Use Non-Stick McPherson Bipolar Forceps, 110mm, 0.5mm Tip with Cable (HNSAG-5110M); Single Use Non-Stick Jeweller Bipolar Forceps, 115mm, 0.5mm Tip with Cable (HNSAG-5115J); Single Use Non-Stick Jeweller Bipolar Forceps, 115mm, 1.0mm Tip with Cable (HNSAG-1115J); Single Use Non-Stick Adson Bipolar Forceps, 120mm, 1.0mm Tip with Cable (HNSAG-1120A); Single Use Non-Stick Adson Bipolar Forceps, 120mm, 0.5mm Tip with Cable (HNSAG-5120A); Single Use Non-Stick Adson Bipolar Force | Hg Innovations, Ltd. | GEI | Class II | 2023-11-20 |
| K232575 | Hair Removal Device, Model(s): R2815-G Pro, R2815-G | Shenzhen Jianchao Intelligent Technology Co., Ltd. | OHT | Class II | 2023-11-20 |
| K231738 | NEUWAVE Microwave Ablation System and Accessories | Neuwave Medical, Inc. | NEY | Class II | 2023-11-16 |
| K231012 | CoolSeal Trinity | Bolder Surgical, LLC | GEI | Class II | 2023-11-15 |
| K232656 | BLU TOTALE (Model: ENEOB852) | Premier North America, Inc. | OLP | Class II | 2023-11-14 |
| K232845 | IPL Cooling Hair Removal Device | Shenzhen Siken 3D Technology Development Co., Ltd. | OHT | Class II | 2023-11-14 |
| K232241 | Disposable Microwave Ablation Needle (T-1408, T-1410, T-1608, T-1610, L-1815, L-1818, L-2015, L-2018) | Betters(Suzhou) Medical Co., Ltd. | NEY | Class II | 2023-11-13 |
| K232240 | Microwave Ablation System (BD-GT) | Betters(Suzhou) Medical Co., Ltd. | NEY | Class II | 2023-11-13 |
| K232488 | Accu-Chek Safe-T-Pro Plus Lancing Device | Roche Diabetes Care, Inc. | FMK | Class II | 2023-11-13 |
| K232509 | Accu-Chek Safe-T-Pro Uno Lancing Device | Roche Diabetes Care, Inc. | FMK | Class II | 2023-11-13 |
| K231277 | TissueStat | Durastat, LLC | NBY | Class II | 2023-11-09 |
| K223682 | Sirius Pintuition Seed, Sirius Pintuition Probe, Sirius Pintuition Base Unit | Sirius Medical Systems B.V. | PBY | Class II | 2023-11-09 |
| K231155 | Biodegradable Medical surgical mask | Guangdong Kingfa Sci. & Tech.Co., Ltd. | FXX | Class II | 2023-11-07 |
| K230100 | SCIZER (SC1-M410) | Classys, Inc. | OHV | Class II | 2023-11-03 |
| K233428 | Easycess Aspiration Pump | Guangzhou Easycess Medical Co.,Ltd | JCX | Class II | 2023-11-03 |
| K232532 | Nd:Yag Laser Therapy Systems | Beijing Unt Technology Co., Ltd. | GEX | Class II | 2023-11-02 |
| K233407 | AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove Clip (LAA0); AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove Clip (ACH1); AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove Clip (ACH2); AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove Clip (PRO1); AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove Clip (PRO2); AtriClip PRO-V LAA Exclusion System (PROV); AtriClip Flex-V LAA Exclusion System with preloaded V Clip (ACHV) | AtriCure, Inc. | PZX | Class II | 2023-11-02 |
| K233402 | Bard 3DMax Mesh | Davol Inc., Subsidiary of C. R. Bard, Inc. | FTL | Class II | 2023-11-01 |
| K231238 | Ultravision2 System | Alesi Surgical, Ltd. | PQM | Class II | 2023-10-31 |
| K231298 | Ultravision2 System Integrated Monopolar L-Hook (H/S) | Alesi Surgical, Ltd. | PQM | Class II | 2023-10-31 |
| K230755 | NuEra Tight RF Model OptiStream | Bios S.R.L. | PBX | Class II | 2023-10-30 |
| K220493 | Plaxpot Multi Plasma | Gcs Co. Limited | QVJ | Class II | 2023-10-27 |
| K230490 | PMD Clean Acne, Model: 4004-CABLUE-NA, 4004-GREY-NA, 4004-YELLOW-NA, 4004-PSTO-NA, 4004-LPUR-NA, 4004-CABLUE-NA-INT, 4004-GREY-INT, 4004-YELLOW-INT, 4004-PSTO-INT, 4004-LPUR-INT | Dongguan Hunter Electronic Technology Co., Ltd. | OLP | Class II | 2023-10-27 |
16,323 clearances in the General, Plastic Surgery panel. Data: openFDA.