Review Panel
General, Plastic Surgery FDA 510(k) Clearances & Devices
- Cleared Devices
- 16,323
- Product Codes (page)
- 38
- Latest Decision
- 2026-03-17
Clearances · page 3 of 164
| K-Number | Trade Name | Applicant / Manufacturer | Product Code | Class | Decision Date |
|---|---|---|---|---|---|
| K253750 | BTL-785NEH | BTL Industries, Inc. | GEI | Class II | 2026-03-17 |
| K260511 | Ulike Reglow Light Therapy Device (UM10) | Shenzhen Ulike Smart Electronics Co., Ltd. | OHS | Class II | 2026-03-16 |
| K254079 | LED Light Therapy Mask (Models: T2, RLD10) | Shenzhen Desida Technology Co., Ltd. | OHS | Class II | 2026-03-16 |
| K253391 | Visualase Cooled Laser Applicator System (9735559); Visualase Cooled Laser Applicator System (9735560); Visualase Cooled Laser Applicator System (9735561) | Medtronic Navigation, Inc. | ONO | Class II | 2026-03-13 |
| K253261 | Apollo Quattro (APQ-10M) | Weero Co., Ltd. | PBX | Class II | 2026-03-13 |
| K260147 | Electric nasal aspirator (BC026, BC025, BC023, BC028, BC029, BC036) | Shenzhen Kingboom Technology Co., Ltd. | BTA | Class II | 2026-03-13 |
| K254233 | MEDPOR Customized Implant Kit | Stryker Leibinger GmbH & Co KG | FWP | Class II | 2026-03-12 |
| K253429 | Genadyne ASTRA NPWT | Genadyne Biotechnologies, Inc. | OMP | Class II | 2026-03-12 |
| K254047 | Hair Removal Device (CT10, CT10 Pro, CT11, CT11 Pro, CT12, CT12 Pro, CTU05, CTU07, CTU09, CTU012, CTU015, CTU X, DT015 Pro, DT015, DT017 Pro, DT017, DT025 Pro, DT025) | Shenzhen Chuangtong Yigou Technology Co., Ltd. | OHT | Class II | 2026-03-11 |
| K254197 | Picasso Pro Diode Laser (002-00460) | CAO Group, Inc. | GEX | Class II | 2026-03-11 |
| K260765 | Gemini NOVA 810+980 Soft Tissue Laser | Azena Medical, LLC | NVK | Class II | 2026-03-10 |
| K253960 | Medicell Mycosis Laser (MCML24004) | Medicell Healthcare Co.,LTD | PDZ | Class II | 2026-03-09 |
| K252888 | NeoSculpt Plus | S&M Medical Co., Ltd. | PBX | Class II | 2026-03-09 |
| K253951 | Holmium Laser Therapeutic Apparatus (HZ-A); Holmium Laser Therapeutic Apparatus (HZ-B); Holmium Laser Therapeutic Apparatus (HZ-E) | Guangzhou Potent Medical Equipment Joint-Stock Co., Ltd. | GEX | Class II | 2026-03-06 |
| K253871 | Klär Lite (RCW-KL1000) | Radcliffe Watts, LLC | FTC | Class II | 2026-03-04 |
| K253878 | LUSTRE GoGlow Advanced LED Patches (PR8001, PR9001) | Shenzhen Kaiyan Medical Equipment Co., Ltd. | OLP | Class II | 2026-03-04 |
| K253920 | CO2 Laser Treatment Machine (CFR3M1) | Haidari Beauty Technology (Beijing) Co., Ltd. | GEX | Class II | 2026-03-03 |
| K252534 | Surgical Face Mask (Ear mount) | Zhejiang Hangkang Medical Equipment Co., Ltd. | FXX | Class II | 2026-03-03 |
| K253874 | LED Therapy Light (COB1400, HP1800PRO) | Shenzhen Hanhua Opto Co., Ltd. | OHS | Class II | 2026-03-03 |
| K252487 | POWERSEAL Open Extended Jaw Sealer and Divider, Double-Action (PS-0021EJDA) | Gyrus Acmi, Inc. | GEI | Class II | 2026-03-02 |
| K253771 | Disposable Microwave Ablation Antenna (DW-XR-II1, DW-XR-II3, DW-XR-II4, DW-XR-II14, DW-XR-II5, DW-XR-II6, DW-XR-II7, DW-XR-II8, DW-XR-II9, DW-XR-II10, DW-XR-II18, DW-XR-II19, DW-XR-II20, DW-XR-II21, DW-DG-II6, DW-DG-II7, DW-DG-II9, DW-DG-II10, DW-DG-II13) | Nanjing Devin Medical Technology Co., Ltd. | NEY | Class II | 2026-03-02 |
| K252632 | Microwave Ablation Device | Nanjing Dewen Medical Technology Co., Ltd. | NEY | Class II | 2026-03-02 |
| K253828 | Medical Alexandrite and Nd:YAG laser Therapy System (CM11LP) | Beijing HuaCheng Taike Technology Co., Ltd. | GEX | Class II | 2026-02-27 |
| K253829 | Medical Ultra-Pico Laser Treatment System (CM-SP-1064&532) | Beijing HuaCheng Taike Technology Co., Ltd. | GEX | Class II | 2026-02-27 |
| K254271 | CAPRI | ORO Co., Ltd. | GEX | Class II | 2026-02-26 |
| K251860 | Copioumed AAMI 3 Surgical Gown | Copioumed International, Inc. | FYA | Class II | 2026-02-26 |
| K252599 | Diode Laser Therapy Systems (WLA-02) | Wingderm Electro-Optics , Ltd. | GEX | Class II | 2026-02-24 |
| K251678 | Swift Ray 1 | Swift Medical, Inc. | QJF | Class II | 2026-02-24 |
| K260287 | SP Electrocautery Device (SP20) | Single Pass, Inc. | GEI | Class II | 2026-02-24 |
| K260377 | XSense Cryoablation System with CryoProbes | IceCure Medical , Ltd. | GEH | Class II | 2026-02-24 |
| K253666 | IPL Hair Removal Device (Models: T31A, T32A) | Shenzhen Mlay Intelligent Technology Co., Ltd. | OHT | Class II | 2026-02-23 |
| K253531 | Alexis® Lighted Wound Protector-Retractor, Rigid, Medium (CL402); Alexis® Lighted Wound Protector-Retractor, Flexible, Medium (CL302) | Applied Medical Resources Corporation | KGW | Class II | 2026-02-23 |
| K253605 | Safety Heel Lancet | Ningbo Medsun Medical Co., Ltd. | FMK | Class II | 2026-02-20 |
| K253683 | FAQ (LED Panel); FAQ (Dual LED Panel) | Foreo, Inc. | OHS | Class II | 2026-02-20 |
| K253398 | Disposable Surgical Mask (Non-Sterile) (EFX3PLBLKMSK300) | Efofex, Inc. | FXX | Class II | 2026-02-19 |
| K253002 | SkinStylus SteriLock MicroSystem (MP1209SL) | Esthetic Medical, Inc. | QAI | Class II | 2026-02-19 |
| K254188 | Meniscus Versaflex | GM Dos Reis Industria e Comercio Ltda. | GAT | Class II | 2026-02-19 |
| K252561 | BTL-754FF | BTL Industries, Inc. | GEX | Class II | 2026-02-18 |
| K251928 | CoolCryo - Cryoapplicator for cardiac cryoablation (CC01-01); CoolCryo - Control console for cardiac cryoablation with liquid nitrogen reservoir (CC01-21) | Medinice S.A. | GEH | Class II | 2026-02-13 |
| K243854 | Contour Light (CL-100) | Contour Research, LLC | OLI | Class II | 2026-02-13 |
| K252490 | Heel Stick Safety Lancet (HHZ-II, HHZ-III, HHZ-IV) | Tianjin Huahong Technology Co., Ltd. | FMK | Class II | 2026-02-12 |
| K254007 | LED Light Therapy Silicone Face Mask (kks-225, kks-280, kks-281) | SZ KKS Silicone&Electronic Co., Ltd. | OHS | Class II | 2026-02-12 |
| K251813 | CURIS II RF Generator (REF 360100-05) | Sutter Medizintechnik GmbH | GEI | Class II | 2026-02-11 |
| DEN250006 | Amferia Wound Dressing | Amferia AB | SHA | Class II | 2026-02-06 |
| K251836 | Dermatrix Duo | Shenzhen Gsd Technology Co., Ltd. | GEI | Class II | 2026-02-06 |
| K253852 | MONOCRYL Plus Antibacterial Poliglecaprone 25 (Monofilament), Sterile Synthetic Absorbable Surgical Suture | ETHICON, Inc. | GAM | Class II | 2026-02-06 |
| K252301 | Henan Yadu Level 4 Surgical Gowns (Reinforced) | Yadu Medical (Henan) Co., Ltd. | FYA | Class II | 2026-02-04 |
| K252048 | 808nm semiconductor laser hair removal machine | Xi'An Taibo Electronic Technology Co., Ltd. | GEX | Class II | 2026-02-03 |
| K252438 | Explant Express | Applied Medical Technology, Inc. | QVS | Class II | 2026-02-03 |
| K254290 | ZenTite (Unicorn+); ZenTite (Unicorn+I); ZenTite (Unicorn+II); ZenTite (Unicorn+III) | Shenzhen Peninsula Medical Group | GEI | Class II | 2026-01-30 |
| K251981 | Boston PICO (Boston PICO) | Boston Aesthetics, Inc. | GEX | Class II | 2026-01-30 |
| K253833 | Facial & Body Beauty Device (model: INIA-BD001, INIA-BD002, INIA-BD003, INIA-BD004, F2C15, F3222 Pro, F5516, F3606, F2210 Pro, F5808, INIA-ED001, INIA-ED002, INIA-BLD001, E1507) | Shenzhen Jianchao Intelligent Technology Co., Ltd. | OHS | Class II | 2026-01-30 |
| K252603 | HIGHERDOSE Body Sculptor (Model: GS-03) | Shenzhen Kaiyan Medical Equipment Co., Ltd. | OHS | Class II | 2026-01-28 |
| K254220 | Reusable 3 Button Fingerswitch Wand | Soniquence, LLC | GEI | Class II | 2026-01-27 |
| K251435 | InbellaIgnite RF System | Inbella Medical, Inc. | GEI | Class II | 2026-01-27 |
| K253633 | Holmium Laser Therapeutic Apparatus (HZ-40) | Guangzhou Potent Medical Equipment Joint-Stock Co., Ltd. | GEX | Class II | 2026-01-24 |
| K252753 | Vydence Family of Lasers | Vydence Medical Industria E Commercio Ltda | GEX | Class II | 2026-01-24 |
| K253712 | LED Light Therapy Mask (RB-051, RB-061, RB-071, RB-052, RB-062, RB-072, RB-053, RB-063, RB-073) | Shenzhen Rainbow Technology Co., Ltd. | OHS | Class II | 2026-01-23 |
| K253761 | HydroMARK Plus Breast Biopsy Site Marker (Dragonfly Shape); HydroMARK Plus Breast Biopsy Site Marker (Hummingbird Shape) | Devicor Medical Products, Inc. | NEU | Class II | 2026-01-23 |
| K252369 | Boston Pico755 | Boston Aesthetics, Inc. | GEX | Class II | 2026-01-21 |
| K252960 | SOLIUS PRO UVB Light Panel | Solius Labs, Inc. | SGZ | Class II | 2026-01-16 |
| K251254 | Ignite RF System | InMode , Ltd. | GEI | Class II | 2026-01-15 |
| K251996 | ENTire IRE System | Entire Medical , Ltd. | GEI | Class II | 2026-01-14 |
| K251524 | Dr. Yglo Skin Tag Remover | Theotclab Healthcare B.V. | GEH | Class II | 2026-01-12 |
| K251988 | Boston iFace (Boston iFace) | Boston Aesthetics, Inc. | GEI | Class II | 2026-01-12 |
| K252830 | Disposable Surgical Face Mask (3P00B, C2900) | Beatles Medical Supplies (Xiantao) Co., Ltd. | FXX | Class II | 2026-01-12 |
| K252906 | ECHELON ENDOPATH Staple Line Reinforcement (ECH60R) | Ethicon Endo-Surgery, LLC | OXC | Class II | 2026-01-09 |
| K253550 | Self-Forming Magnet (Flexagon Plus OTOLoc) | GI Windows, Inc. | SAH | Class II | 2026-01-09 |
| K253924 | PuraStat | 3-D Matrix Europe SAS | QAU | Class II | 2026-01-07 |
| K250341 | Sensilift Pro (ST300XXYYZZZ) | El Global Trade, Ltd. | PAY | Class II | 2026-01-06 |
| K252650 | Disposable Medical Face Mask | Makrite Industries, Inc. | FXX | Class II | 2026-01-05 |
| K253867 | FiberLocker Implant ; FiberLocker Instrument ; FiberLocker PowerUnit | ZuriMED Technologies AG | OWX | Class II | 2026-01-02 |
| K253888 | MOLLI 2 System | Stryker Endoscopy | NEU | Class II | 2025-12-31 |
| K253881 | Intense Pulsed Light (IPL) System (Models: T033KQ, T033KD, T033KF, T033MQ, T033MD, T033MF, T055KQ, T055KD, T055KH, T505KQ, T505KH, T505KF, SL-B505WM) | Shenzhen Fansizhe Science and Technology Co., Ltd. | OHT | Class II | 2025-12-29 |
| K253279 | Feather/numiere 05 06 07 (05) | Heat IN A Click, LLC | OHS | Class II | 2025-12-24 |
| K253342 | PICO-K | Speclipse, Inc. | GEX | Class II | 2025-12-24 |
| K253400 | LED Light Therapy Face Mask (FM60X, FM60X-B, FM60X-W, FM80-W, FM80, VAP1, FM100X, FM100X-B, FM100X-W) | Shenzhen Saidi Light Therapy Technology Co., Ltd. | OHS | Class II | 2025-12-24 |
| K253754 | Philips Lumea IPL | Philips Consumer Lifestyle B.V. | OHT | Class II | 2025-12-23 |
| K253135 | LED Light Therapy Device (HLGMZ-3W-G1V1,HLGMZ-3W-G2V1,HLG-GJXJ-G1V1,HGMZ-2W-G1V1, HGMZ-2W-G2V1,MRD-GJXJ-G1V1.) | Dongguan Yijiaming Technology Co., Ltd. | OHS | Class II | 2025-12-23 |
| K253781 | InnoClip Clip Applier | Taiwan Surgical Corporation | FZP | Class II | 2025-12-22 |
| K252743 | STRATAFIX Spiral PDS Plus Knotless Tissue Control Device; STRATAFIX Spiral MONOCRYL Plus Knotless Tissue Control Device | ETHICON, Inc. | GAM | Class II | 2025-12-22 |
| K243342 | KP Protective Face Mask | Kp Trading Co., Ltd. | FXX | Class II | 2025-12-22 |
| K253903 | InnoClip Disposable Clip Applier | Taiwan Surgical Corporation | FZP | Class II | 2025-12-22 |
| K253086 | LED Light Therapy Device (Models: SG-FM, SG-FE) | Sunglor Technology Co., Ltd. | OHS | Class II | 2025-12-19 |
| K252877 | SANDRO Dual | Wontech Co., Ltd. | GEX | Class II | 2025-12-19 |
| K252892 | SCOUT MD Surgical Guidance System | Merit Medical Systems, Inc. | NEU | Class II | 2025-12-19 |
| K253054 | LED Light Therapy Mask (M19, M19-1, M19-2, M19-3, M19-5, M19-6) | Shenzhen Xinlong Precision Plastic Mold Products Co., Ltd. | OHS | Class II | 2025-12-19 |
| K250998 | CO2 Laser Therapy System (Model: LFS-D9U) | Sanhe Lefis Electronics Co., Ltd. | GEX | Class II | 2025-12-19 |
| K251077 | JOULE 1064nm System and Accessories | Sciton, Inc | GEX | Class II | 2025-12-19 |
| K253915 | MOVIVA® Hybrid Ablation Probe | Erbe Elektromedizin GmbH | GEI | Class II | 2025-12-18 |
| K252739 | ETHICON 4000 45mm Compact Stapler (EC3DT45C); ETHICON 4000 45mm Standard Stapler (EC3DT45S); ETHICON 4000 45mm Long Stapler (EC3DT45L); ETHICON 3D 45mm White Reload (ER45W); ETHICON 3D 45mm Blue Reload (ER45B); ETHICON 3D 45mm Green Reload (ER45G); ETHICON 3D 45mm Black Reload (ER45T) | Ethicon Endo-Surgery, LLC | GDW | Class II | 2025-12-17 |
| K252983 | Wrinkle Retreat Pro Light Therapy Face Mask (Model: PH-m03) | Shenzhen Goodwind Technology Development Co., Ltd. | OHS | Class II | 2025-12-17 |
| K252940 | VR® Personal Protective Level 3 Gown (VR Gowns) | PolyConversions, Inc. | QPC | Class II | 2025-12-16 |
| K252111 | Versius Surgical System (Versius Plus) | Cmr Surgical Limited | SCV | Class II | 2025-12-16 |
| K253620 | TroClose 1200 | Gordian Surgical, Ltd. | GAM | Class II | 2025-12-16 |
| K252574 | Erchonia CLX (Model # CFL) | Erchonia Corporation | OLI | Class II | 2025-12-15 |
| K251989 | VizMark Preloaded Tissue Marker Device (VM-0001) | Breast-Med, Inc. | NEU | Class II | 2025-12-12 |
| K252745 | Halo Sterile Single-use Radial Fiber (Halo-R-0.40-2.5/Halo-R-0.60-2.5/Novo-R-0.60-1.8/Novo-R-0.40-1.8) | Micro-Energy Medical Technology Co., Ltd. | GEX | Class II | 2025-12-12 |
| K252941 | HALYARD* Adult Face Mask with SO SOFT* Lining and SO SOFT* Earloops | O&M Halyard, Inc. | FXX | Class II | 2025-12-11 |
| K253706 | Lancing device (HH-XV-T) | Tianjin Huahong Technology Co., Ltd. | QRL | Class II | 2025-12-09 |
16,323 clearances in the General, Plastic Surgery panel. Data: openFDA.