Review Panel
General, Plastic Surgery FDA 510(k) Clearances & Devices
- Cleared Devices
- 16,323
- Product Codes (page)
- 38
- Latest Decision
- 2025-09-15
Clearances · page 5 of 164
| K-Number | Trade Name | Applicant / Manufacturer | Product Code | Class | Decision Date |
|---|---|---|---|---|---|
| K251914 | IPL Hair Removal Device (MLY-M011); IPL Hair Removal Device (MLY-M012); IPL Hair Removal Device (MLY-M013); IPL Hair Removal Device (MLY-M015); IPL Hair Removal Device (MLY-T001); IPL Hair Removal Device (MLY-T002) | Miley Technology (Hebei) Co., Ltd. | OHT | Class II | 2025-09-15 |
| K252189 | LED Light Therapy Mask (2311, 2344, 2457, 2458) | Dongguan Yanxi Technology Co., Ltd. | OHS | Class II | 2025-09-12 |
| K252225 | PowerKnot High Strength Sutures | Medacta International S.A. | GAT | Class II | 2025-09-12 |
| K251843 | Erchonia EVRL | Erchonia Corporation | OLP | Class II | 2025-09-12 |
| K252576 | Legend X Platform | Pollogen, Ltd. | GEI | Class II | 2025-09-12 |
| K251826 | RENASYS WOUND+ Dressing Kit with AIRLOCK Technology | Smith & Nephew Medical, Ltd. | OMP | Class II | 2025-09-11 |
| K250734 | OptiLUV Device | Pollogen, Ltd. | PBX | Class II | 2025-09-10 |
| K250483 | PhotonBlade 3; PhotonBlade 3 Smoke Evacuation | Stryker Instruments | GEI | Class II | 2025-09-09 |
| K251545 | Intense Pulsed Light Therapy Device (MMABM-1) | Micowey Medical Equipment (Guangxi) Co., Ltd. | ONF | Class II | 2025-09-04 |
| K251510 | Symani Surgical System | Medical Microinstruments, Inc. | SAQ | Class II | 2025-09-04 |
| K251781 | KALA MINI 2.0 (KALA-04) | Shenzhen Kaiyan Medical Equipment Co., Ltd. | OHS | Class II | 2025-09-04 |
| K251298 | Mobile Laser Unit (1001-N2); Thermoguide Workstation (1100-N1); Laser Applicator (4012-N5, 4017-N2, 4017-N4); MR Introducer (4013-N6) | Clinical Laserthermia Systems, AB | ONO | Class II | 2025-09-04 |
| K251457 | Diode laser therapy device (VADER) | Beijing Superlaser Technology Co., Ltd. | GEX | Class II | 2025-09-03 |
| K250217 | AGNES Ultra | Agnes Medical Co., Ltd. | GEI | Class II | 2025-09-03 |
| K231952 | MEDILIGHT | Medicreations, LLC | ONF | Class II | 2025-09-03 |
| K251108 | Erbe ESU Model VIO® 3n with Accessories | Erbe Elektromedizin GmbH | GEI | Class II | 2025-08-29 |
| K251727 | GLAM LED Facial Mask (TB-2386F) | Touchbeauty Beauty & Health (Shenzhen) Co., Ltd. | GEX | Class II | 2025-08-29 |
| K250261 | Heager Medical Laser Family (Sabrina/Adolf) | Heager GmbH | GEX | Class II | 2025-08-26 |
| K243800 | PRO Pen Microneedling System (6883) | Dermalogica, LLC | QAI | Class II | 2025-08-25 |
| K251588 | LED Light Therapy Mask (FCM902, FCM905, FCM906, FCM908, 11-001-RBMASK, FCM910) | Shenzhen Fittop Health Technology Co., Ltd. | OHS | Class II | 2025-08-21 |
| K243713 | Single Use RF Surgical Electrode (Needle Type) (AN-B, AN-C, AN-E, AN-I, AN-S, AN-W3A, AN-F3A, AN-IL, AN-SL, AN-W3B, AN-F1A, AN-F3B, AN-B3A) | Agnes Medical Co., Ltd. | GEI | Class II | 2025-08-19 |
| K250313 | Sterile Powder Free Synthetic Rubber Surgeons Gloves, Green Color, Tested For Use With Chemotherapy Drugs and Gastric Acid | Harps Europe Manufacturing GmbH | KGO | Class I | 2025-08-19 |
| K252316 | Venclose digiRF Generator (VCRFG1); Venclose EVSRF Catheter (VC10A256F60, VC10A256F100) | Venclose, Inc. | GEI | Class II | 2025-08-19 |
| K251871 | FEATHER 01 02 03 04 (Model:01) | Heat IN A Click, LLC | OHS | Class II | 2025-08-15 |
| K250916 | WinForth (LM-E470KA) | Shenzhen Leaflife Technology Co., Ltd. | PBX | Class II | 2025-08-14 |
| K251012 | TRUDERMAL Pro (ZLD-390) | Shenzhen Kaiyan Medical Equipment Co., Ltd. | OHS | Class II | 2025-08-14 |
| K251176 | IPL Hair Removal Device (Model(s): T14B, T16B, T19B, T15B, T17C, T18B, T21A, T21B, T21C, T21D, T22A, T22B, T25B, T25C) | Shenzhen Mlay Intelligent Technology Co., , Ltd. | OHT | Class II | 2025-08-14 |
| K243279 | DOLORCLAST Focused Shock Waves | E.M.S Electro Medical Systems S.A | PZL | Class II | 2025-08-13 |
| K252201 | HS Fiber | Riverpoint Medical | GAT | Class II | 2025-08-13 |
| K252083 | HOTWIRE System RF Generator and Footswitch (optional accessory) | Atraverse Medical, Inc. | GEI | Class II | 2025-08-12 |
| K252211 | Duoblade Plus SE (DB1EP, DB1EP-T, DB1EP-H, DB1EP-TH); Duoblade Prime (DB1P, DB1P-T, DB1P-H, DB1P-TH) | Cnc Technologies | GEI | Class II | 2025-08-11 |
| K251327 | XERF | Lutronic Corporation | GEI | Class II | 2025-08-11 |
| K251801 | Diode laser device (BM091) | Hebei Newangie Technology Co., Ltd. | GEX | Class II | 2025-08-08 |
| K250718 | swiftPro System (SWF-SPS); Swift System (SWF-SYS) | Emblation Limited | NEY | Class II | 2025-08-08 |
| K251667 | LED Light Therapy Mask (M01, M02, M06, M07, M08, M09) | Shenzhen Liyoutong Technology Co., Ltd. | OHS | Class II | 2025-08-07 |
| K251432 | Olo | El.En S.P.A. | GEX | Class II | 2025-08-06 |
| K250950 | CUTIVA Topical Skin Adhesive (RM1700); CUTIVA PLUS Skin Closure System (RM1739) | Okapi Medical, LLC Dba Resivant Medical | MPN | Class II | 2025-08-04 |
| K250541 | Self-Forming Magnet (Flexagon Plus OTOLoc) | GI Windows, Inc. | SAH | Class II | 2025-08-01 |
| K251707 | IPL Hair Removal Device (HCT-1208/HCT-1208B/HCT-1208L) | Shenzhen Huachuangtong Industrial Co., Ltd. | OHT | Class II | 2025-08-01 |
| K244060 | eCO2 3D | Lutronic Corporation | ONG | Class II | 2025-07-31 |
| K251076 | Diode Laser Hair Removal Machine (models: T60A, T60B, T60C, T60D, T60E) | Shenzhen Lifotronic Technology Co., Ltd. | GEX | Class II | 2025-07-30 |
| K251339 | Medical Diode Laser Hair Removal Device (PZ-606¿, PZ-BDT68-01, PZ-BDT68-02, PZ-BDT68-03, PZ-BDT68-04) | Zhengzhou PZ Laser Slim Technology Co., Ltd. | GEX | Class II | 2025-07-25 |
| K252215 | InbellaMAX System | Inbella Medical , Ltd. | GEI | Class II | 2025-07-25 |
| K251955 | Onflex Mesh | Davol Inc., Subsidiary of C. R. Bard, Inc. | FTL | Class II | 2025-07-24 |
| K252056 | Isolator® Synergy EnCompass Clamp and Guide system (OLH, OSH, GPM100) | AtriCure, Inc. | OCL | Class II | 2025-07-24 |
| K251984 | 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 | 2025-07-24 |
| K251265 | Resilience Fully Covered Esophageal Stent System | Merit Medical Systems, Inc. | ESW | Class II | 2025-07-23 |
| K251748 | MammoSTAR Biopsy Site Identifier | Carbon Medical Technologies, Inc. | NEU | Class II | 2025-07-23 |
| K251255 | LymphaTech Mobile 3D Measuring Tool | Lymphatech, Inc. | SFG | Class I | 2025-07-22 |
| K251655 | VersaCoat Tendon Protector (VTP-44G2); VersaCoat Tendon Protector (VTP-12G1) | Alafair Biosciences | OWW | Class II | 2025-07-18 |
| K251844 | Kerecis SurgiBind (50241) | Kerecis Limited | OXH | Class II | 2025-07-15 |
| K242237 | Jewel Soft Tissue Reinforcement Device (102-6005) | Xiros Limited | QUW | Class II | 2025-07-15 |
| K251173 | Intense Pulsed Light (IPL) System (T033KQ, T033KD, T033KF, T033MQ, T033MD, T033MF, T055KQ, T055KD, T055KH, T002AQ, T002AD, T002AF, T002BQ, T002BD, T002BF, T050KQ, T050KD, T050KF) | Shenzhen Fansizhe Science and Technology Co., Ltd. | OHT | Class II | 2025-07-14 |
| K250504 | Leonardo Duster | Ceramoptec GmbH | GEX | Class II | 2025-07-14 |
| K250761 | KALA Therapy Wand (Model: KALA-03) | Shenzhen Kaiyan Medical Equipment Co., Ltd. | OHS | Class II | 2025-07-11 |
| K250942 | Ice Cooling IPL Hair Removal Device (UI20S DB, UI20S RE, UI20S PW, UI20S GP, UI20S GR, UI20S BK, UI20 DB, UI20 RE, UI20 PW, UI20 GP, UI20 GR, UI20 BK) | Shenzhen Ulike Smart Electronics Co., Ltd. | OHT | Class II | 2025-07-11 |
| K251149 | AviClear Laser System | Cutera, Inc. | GEX | Class II | 2025-07-11 |
| K251759 | Flexiva Pulse Laser Fiber; Flexiva Pulse TracTip Laser Fiber; Flexiva Pulse ID Laser Fiber; Flexiva Pulse ID TracTip Laser Fibers | Boston Scientific Corporation | GEX | Class II | 2025-07-09 |
| K251761 | Anovo Surgical System (Model 6Ne); Anovo Instrument ARM Curved Scissors ; Anovo Instrument ARM Hook Electrode | Momentis Surgical , Ltd. | QNM | Class II | 2025-07-08 |
| K250065 | DENSITY; DENZA; DENSITY Noir | Jeisys Medical Incorporated | GEI | Class II | 2025-07-08 |
| K243123 | IPL Treatment Device (MDSQMC-01) | Medusa (Guangxi)Medical Devices Co., Ltd. | ONF | Class II | 2025-07-03 |
| K250165 | Pastelle | Wontech Co., Ltd. | GEX | Class II | 2025-07-03 |
| K251054 | Hem-o-lok PurplePlus Large Polymer Ligating Clips | Teleflex Medical | FZP | Class II | 2025-07-03 |
| K251031 | Fiber Laser Treatment Systems (HS-232,HS-233) | Shanghai Apolo Medical Technology Co., Ltd. | ONG | Class II | 2025-07-02 |
| K250779 | CS-Pro MED | Curative Sound Therapeutics | PZL | Class II | 2025-07-02 |
| K251049 | SurgiLight 1470 Diode Laser System (Model:Halo) | Micro-Energy Medical Technology Co., Ltd. | GEX | Class II | 2025-07-02 |
| K243701 | AuroLase® System | Nanospectra Biosciences, Inc. | GEX | Class II | 2025-07-02 |
| K250016 | droplet® personal lancets | Htl-Strefa S.A | QRK | Class II | 2025-07-01 |
| K251000 | Hand-held Hair Removal Device (FZ-200A, FZ-201, FZ-202, CT05, CT06, CT07, CT08, CT09) | Shenzhen Chuangtong Yigou Technology Co., Ltd. | OHT | Class II | 2025-06-30 |
| K251329 | Diode laser device (RF3120-BI) | Risu Medical Technology Co., Ltd. | GEX | Class II | 2025-06-27 |
| K243187 | Nisus ONE Negative Pressure Wound Therapy System (OCMPP-100) | Cork Medical | OMP | Class II | 2025-06-27 |
| K251694 | safety lancet | Tianjin Huahong Technology Co., Ltd. | FMK | Class II | 2025-06-26 |
| K251632 | Optimas MAX System | InMode , Ltd. | GEX | Class II | 2025-06-26 |
| K250966 | CurrentBody Skin LED Light Therapy Mask Series 2 (MK-90H) | Shenzhen Kaiyan Medical Equipment Co., Ltd. | OHS | Class II | 2025-06-25 |
| K250880 | LED LIGHT MASK (A093) | Foshan Guangyu Weilai Medical Equipment Co., Ltd. | OHS | Class II | 2025-06-20 |
| K243978 | LED Facial Mask | Shenzhen Sunsred Technology Co.,Ltd | OHS | Class II | 2025-06-20 |
| K243120 | HybridAPC probe | Erbe Elektromedizin GmbH | GEI | Class II | 2025-06-20 |
| K251224 | Restrata Soft Tissue Reinforcement (STR) | Acera Surgical, Inc. | OXF | Class II | 2025-06-20 |
| K251235 | Electrosurgical Pads | Baisheng Medical Co., Ltd. | GEI | Class II | 2025-06-19 |
| K250082 | Procedure mask/Surgical mask/Face mask | Winner Medical Co., Ltd. | FXX | Class II | 2025-06-18 |
| K250997 | Integrity Implant | Anika Therapeutics, Inc. | OWX | Class II | 2025-06-17 |
| K243036 | IPL Hair Removal Device (BHRL-01, BHRL-02, BHRL-03, BHRL-04, BHRL-05, BHRL-06, BHRL-06B, BHRL-07, BHRL-08, BHRL-09, BHRL-10, BHRL-11, BHRL-12, BHRL-13, BHRL-14, BHRL-15, BHRL-16, BHRL-17, BHRL-18, BHRL-19, BHRL-20, BHRL-21, BHRL-22, BHRL-23, BHRL-24, BHRL-25, BHRL-26, BHRL-27, BHRL-28, BHRL-29) | Bestway Plastic and Metal Products , Ltd. | OHT | Class II | 2025-06-15 |
| K243638 | MV Flow Aspiration Pump (MVFLOWPMP01) | Microvention | JCX | Class II | 2025-06-13 |
| K250782 | Fractional CO2 Laser Machine | Zhengzhou PZ Laser Slim Technology Co., Ltd. | GEX | Class II | 2025-06-12 |
| K250936 | Q-Switched Nd:YAG Laser (SHE-LSP101-1) | Beijing Sano Laser S&T Development Co.,Ltd | GEX | Class II | 2025-06-12 |
| K251557 | Bard® Mesh; Bard® Mesh Pre-Shaped | Davol, Inc. | FTL | Class II | 2025-06-12 |
| K243683 | Deka Bluebeam | El.En S.P.A. | GEX | Class II | 2025-06-12 |
| K243482 | Self-Forming Magnet (Flexagon) | GI Windows, Inc. | SAH | Class II | 2025-06-11 |
| K250735 | Dental Barrier and Sleeves | Fomed Industries, Inc. | PEM | Class II | 2025-06-10 |
| K242996 | EndyMed PRO MAX | Endymed Medical, Ltd. | GEI | Class II | 2025-06-10 |
| K250465 | CO2 Laser Machine (Lume) | Nanjing Bestview Laser S&T Co., Ltd. | GEX | Class II | 2025-06-09 |
| K250830 | LED Light Therapy Mask (G15, G15P, G15K, G11P, G11, G10, G13, G14, G17, VISO, PRANA, Chin2Chest, BBL-FACEMASK) | Shenzhen Sungrow Led Technology Co., Ltd. | OHS | Class II | 2025-06-09 |
| K250746 | Magnetic Surgical System | Levita Magnetics International Corp | PNL | Class II | 2025-06-07 |
| K250109 | TYBR Collagen Gel | Tybr Health | OWY | Class II | 2025-06-06 |
| K250591 | Anovo Surgical System (6Ne) | Momentis Surgical , Ltd. | QNM | Class II | 2025-06-06 |
| K240983 | Discovery Pico; Discovery Pico Plus; Discovery Pico Derm | Quanta System Spa | GEX | Class II | 2025-06-06 |
| K251042 | Light Therapy System (M500, L6) | Guangzhou Ahead Intelligent Technology Co., Ltd. | OHS | Class II | 2025-06-06 |
| K250722 | Nd: YAG Laser Therapy System (QN-1) | Hebei JT Medical Co., Ltd. | GEX | Class II | 2025-06-06 |
| K242907 | DELPHI System | CnS Medical Co., Ltd. | GEI | Class II | 2025-06-06 |
| K251450 | Baby Nasal Aspirator (BN002); Baby Nasal Aspirator (BN006); Baby Nasal Aspirator (BN007); Baby Nasal Aspirator (BN008); Baby Nasal Aspirator (BN009) | Shenzhen Desida Technology Co., Ltd. | BTA | Class II | 2025-06-06 |
16,323 clearances in the General, Plastic Surgery panel. Data: openFDA.