Review Panel
General, Plastic Surgery FDA 510(k) Clearances & Devices
- Cleared Devices
- 16,323
- Product Codes (page)
- 29
- Latest Decision
- 2022-08-23
Clearances · page 17 of 164
| K-Number | Trade Name | Applicant / Manufacturer | Product Code | Class | Decision Date |
|---|---|---|---|---|---|
| K221546 | OneTouch Delica Plus Lancing System | Asahi Polyslider Co., Ltd. | QRL | Class II | 2022-08-23 |
| K221604 | SafetiHeel, MediHeel, Novaplus | Nsp Tech Pte, Ltd. | FMK | Class II | 2022-08-22 |
| K203078 | CAREWE Surgical Face Mask Models N001-AW, N002-AW, and N003-AW | Huizhou Tianchang Industrial Co., Ltd. | FXX | Class II | 2022-08-19 |
| K222272 | truFreeze Console, PN CC301; Aire PV Passive Venting Catheter, PN CO840703; 16 Fr CDT 5 Pack, PN 2000181; 20Fr CDT 5 Pack, PN ACCCC3CDT05; Active Venting Spray Kit, 20 Fr CDT, PN 2000177; Active Venting Spray Kit 16 Fr CDT, PN 20000516; Rapid AV Catheter 5 Pack, PN 2000184 | STERIS Corporation | GEH | Class II | 2022-08-18 |
| K220387 | Disposable Blood Lancets | Suzhou Kyuan Medical Apparatus Co., Ltd. | QRL | Class II | 2022-08-17 |
| K221838 | Surgical Face Mask (HNFM0103) | Shanghai Hua EN Industrial Co, Ltd. | FXX | Class II | 2022-08-17 |
| K212273 | Cross Protection ResQ300 Plus Surgical Face Mask | Cross Protection (M) Sdn Bhd | FXX | Class II | 2022-08-17 |
| K212790 | XLase Plus | Biotec Italia, Srl | GEX | Class II | 2022-08-15 |
| K221027 | Isolation Gown (S, M, L, XL, XXL (Yellow, Blue)) | Allmed Medical (Hubei) Protective Products Co., Ltd. | FYC | Class II | 2022-08-12 |
| K220385 | Intense Pulsed Light Equipment | Beijing Globalipl Development Co., Ltd. | ONF | Class II | 2022-08-12 |
| K221466 | IPL Hair Removal Device, model: AI01, AI06, AI08, AI16, AI17 | Shenzhen Century Dongyuan Technology CO , Ltd. | OHT | Class II | 2022-08-12 |
| K221126 | Unistik® 3, sterile single-use safety lancets; Unistik® 3 Value, sterile single-use safety lancets; Abbott SF sterile single-use safety lancets | Owen Mumford, Ltd. | FMK | Class II | 2022-08-12 |
| K221131 | Tasso+ | Tasso, Inc. | FMK | Class II | 2022-08-12 |
| K220472 | NEUWAVE Microwave Ablation System and Accessories | Neuwave Medical, Inc. | NEY | Class II | 2022-08-11 |
| K221789 | IRIS Pi Q switched Nd YAG laser | Bio-Med USA, Inc. | GEX | Class II | 2022-08-09 |
| K212810 | MONOFIX PGCL, knotless wound closure device | Samyang Holdings Corp., Ltd. | GAM | Class II | 2022-08-05 |
| K221336 | Avéli | Revelle Aesthetics, Inc. | OUP | Class II | 2022-08-05 |
| K221671 | CellFX® System | Pulse Biosciences, Inc. | GEI | Class II | 2022-08-01 |
| K221451 | IPL hair removal | Shenzhen Lizbella Technology Co.,Ltd | OHT | Class II | 2022-08-01 |
| K221907 | RhinAer® Stylus (FG1393) | Aerin Medical, Inc. | GEI | Class II | 2022-07-29 |
| K221945 | Beamer AVEO FILTER INTEGRATED ARGON PROBE 1.8mm x 160 cm, Beamer AVEO FILTER INTEGRATED ARGON PROBE 1.8 mm X 320 cm, Beamer AVEO FILTER INTEGRATED ARGON PROBE 2.3 mm X 230 cm, Beamer AVEO FILTER INTEGRATED ARGON PROBE 2.3 mm x 320 cm, Beamer AVEO FILTER INTEGRATED ARGON SIDEFIRE PROBE 2.3 mm x 230 cm | Conmed Corporation | GEI | Class II | 2022-07-28 |
| K213252 | Dornier Thulio | Dornier Medtech America, Inc. | GEX | Class II | 2022-07-27 |
| K220876 | AOK 95A Medical Mask (20200049) | Aok Tooling Limited | FXX | Class II | 2022-07-27 |
| K221430 | reVive Light Therapy LED Cleansing System | Led Technologies, Inc. | OHS | Class II | 2022-07-27 |
| K214112 | Invia Ease Negative Pressure Wound Therapy (NPWT) System | Medela AG | OMP | Class II | 2022-07-26 |
| K221409 | Paneffort 3-ply Surgical and Procedural Masks | Paneffort, LLC | FXX | Class II | 2022-07-25 |
| K221234 | TargetCool | Recensmedical, Inc. | GEH | Class II | 2022-07-22 |
| K221196 | Disposable Medical Face Mask (ear loop) | Xiantao Topmed Nonwoven Protective Products Co., Ltd. | FXX | Class II | 2022-07-22 |
| K220064 | Synergy Marble (Model: Opasm) | Yrs Group, Inc. | OHS | Class II | 2022-07-22 |
| K211399 | Sterile Level 3 Surgical Gown | Barco Tekstil Sanayi VE Ticaret A.S. | FYA | Class II | 2022-07-22 |
| K213813 | DuraFuse Clip and Applier System | Neuramedica, Inc. | FZP | Class II | 2022-07-22 |
| K221363 | AF Laser | ShenB Co., Ltd. | PDZ | Class II | 2022-07-20 |
| K213761 | Joule diVa System | Sciton, Inc | GEX | Class II | 2022-07-19 |
| K220777 | Surgical face mask | Hubei Qianjiang Kingphar Medical Material Co., Ltd. | FXX | Class II | 2022-07-19 |
| K221151 | Beauty LED Mask, Model: KFB265 | Hunan Guangye Biotechnology Co., Ltd. | OHS | Class II | 2022-07-19 |
| K221433 | Facet 28G Universal Lancet | Facet Technologies, LLC | QRK | Class II | 2022-07-15 |
| K220970 | Renuvion APR Handpiece | Apyx Medical Corporation(Formerly Bovie Medical Corporation) | GEI | Class II | 2022-07-15 |
| K212073 | Alma Diode Tabletop Laser | Alma Lasers , Ltd. | GEX | Class II | 2022-07-14 |
| K203013 | AGNES | Agnes Medical Co., Ltd. | GEI | Class II | 2022-07-14 |
| K220560 | Dermatac Drape | 3M | OMP | Class II | 2022-07-14 |
| K221407 | truSculpt iD | Cutera, Inc. | GEI | Class II | 2022-07-13 |
| K221083 | Smartlux Mini | Medmix Co., Ltd. | GEX | Class II | 2022-07-12 |
| K220643 | DropSafe Acti-Lance Safety Lancets; droplet ACTI-LANCE Safety Lancets, DropSafe Medlance Plus Safety Lancets; droplet MEDLANCE PLUS Safety Lancets, DropSafe ergoLance Safety Lancets, DropSafe Prolance Safety Lancets, DropSafe Medisafe Solo Safety Lancets; DropSafe Haemolance Plus Safety Lancets | Htl-Strefa S.A | FMK | Class II | 2022-07-08 |
| K220424 | Through the Scope Tracheal Stent System | Micro-Tech (Nanjing) Co., Ltd. | JCT | Class II | 2022-07-08 |
| K221679 | IPL Hair Remover, Model: G993, G996, G998 and G885 | Shenzhen Mywin Technology Co., Ltd. | OHT | Class II | 2022-07-07 |
| K212472 | AgeJet | Triworks Group Srl | GEI | Class II | 2022-07-07 |
| K213056 | LED Facial Mask | Shenzhen Osto Technology Company Limited | OLP | Class II | 2022-07-07 |
| K221246 | IPL Hair Removal (Model: SL-B080, SL-B126, SL-B136) | Shenzhen Semlamp Intelligent Technology Co., Ltd. | OHT | Class II | 2022-07-07 |
| K220475 | Lancet (I, II, III, V, VI); Lancing device (HH-X-T, HH-XIII-T, HH-XV-T, HH-XVI-T, HH-XVII-T, HH-XVIII-T, HH-XIX, HH-XXI-T, HH-XXII-T, HH-XXIII-T, HH-XXIV-T) | Tianjin Huahong Technology Co., Ltd. | QRL | Class II | 2022-07-06 |
| K221173 | Surgical Mask (Model: 0868F, 0866F) | Jiangxi Sanhao Medical Instruments Co.,Ltd | FXX | Class II | 2022-07-06 |
| K220660 | Prevena Restor Adapti-Form Dressing | 3M Healthcare Business Group | OMP | Class II | 2022-07-01 |
| K220248 | Home use hair removal device | Shenzhen Mareal Tech Co., Ltd. | OHT | Class II | 2022-07-01 |
| K211150 | Dental diode laser, SOGA Laser, ILaser II | Shenzhen Soga Technology Co., Ltd. | NVK | Class II | 2022-07-01 |
| K220500 | Ergoline Vitality Total Light 3, Planet Fitness 50/4 TLT by Ergoline, Planet Fitness 42/3 TLT by Ergoline, Ergoline Vitality Hybrid Light 3, Ergoline Vitality Hybrid Light, Planet Fitness 50/4 HLT by Ergoline, Planet Fitness 46/3 HLT by Ergoline, Ergoline Vitality Pure Light 3, Ergoline Vitality Pure Light, Planet Fitness 50/4 PLT III by Ergoline, Planet Fitness 50/4 PLT by Ergoline, Planet Fitness 46/3 PLT by Ergoline, Planet Fitness 42/3 PLT by Ergoline | Jk-Holding GmbH | LEJ | Class II | 2022-07-01 |
| K220378 | Sparta 3-Ply Surgical Disposable Face Mask | Sparta East, LLC | FXX | Class II | 2022-06-30 |
| K221571 | InMode Multi-system | InMode , Ltd. | GEX | Class II | 2022-06-30 |
| K221569 | Intense Pulsed Light (IPL) System, model: T013C, T015C, T015K | Shenzhen Fansizhe Science and Technology Co., Ltd. | OHT | Class II | 2022-06-30 |
| K221312 | Diode Laser Hair Removal Device | Guangzhou Chuang Zao Mei Technology Co., Ltd. | GEX | Class II | 2022-06-29 |
| K220670 | Magnum | Magnum Health and Safety Pvt, Ltd. | FXX | Class II | 2022-06-28 |
| K221272 | Medical Face Mask | Shandong Xingyu Gloves Co., Ltd. | FXX | Class II | 2022-06-28 |
| K221273 | Medical Face Mask (M001) | Xingyu Medical Tech Co., Ltd. | FXX | Class II | 2022-06-28 |
| K213726 | PL-1 Skin Treatment System | AVAVA, Inc. | GEX | Class II | 2022-06-28 |
| K213786 | CiRX Single use electrosurgical pencil with non-coated and coated electrode | Ningbo Shun YE Medical Company, Ltd. | GEI | Class II | 2022-06-27 |
| K213250 | Secret Duo | Ilooda Co,., Ltd. | GEX | Class II | 2022-06-24 |
| K220377 | Procedure Mask | Little Rapids Corporation | FXX | Class II | 2022-06-24 |
| K211173 | maxmorespine Bipolar Electrodes | Hoogland Spine Products, GmbH | GEI | Class II | 2022-06-23 |
| K213612 | SYLFIRM X | VIOL Co., Ltd. | GEI | Class II | 2022-06-23 |
| K220586 | Symbotex Composite Mesh, ProGrip Self-Gripping Polyester Mesh, Parietex Hydrophilic 2D 3D Anatomical Mesh, Versatex Monofilament Mesh | Sofradim Production | FTL | Class II | 2022-06-22 |
| K221482 | Esophageal TTS Stent | Taewoong Medical Co., Ltd. | ESW | Class II | 2022-06-22 |
| K211979 | Lumenis Y&R Laser System | Lumenis, Inc. | GEX | Class II | 2022-06-21 |
| K211099 | Freezen Clear Skin Clinic Warts & Tags | Cryoconcepts LP | GEH | Class II | 2022-06-17 |
| K212871 | Aliya(TM) System, Aliya(TM) Generator, Aliya(TM) Needle, Aliya(TM) Electrode | Galvanize Therapeutics, Inc. | OAB | Class II | 2022-06-17 |
| K220550 | Disposable Surgical Face Mask (M663BE, M663BT) | Makrite Industries, Inc. | FXX | Class II | 2022-06-14 |
| K220528 | Surgical Isolation Cover Gown | Wuhan Dymex Healthcare Co., Ltd. | FYC | Class II | 2022-06-10 |
| K212024 | PAL System | Microaire Surgical Instruments, LLC | QPB | Class II | 2022-06-10 |
| K221368 | Promisemed Blood Lancet, VeriFine Safety Lancet, VeriFine Mini-Safety Lancet | Promisemed Hangzhou Meditech Co., Ltd. | FMK | Class II | 2022-06-09 |
| K211000 | ACUTRON | Ilooda Co,., Ltd. | GEI | Class II | 2022-06-09 |
| K220729 | The Luminance RED Acne Device | Luminance Medical Ventures, Inc. | OLP | Class II | 2022-06-09 |
| K212663 | HELIOS IV 785 | Laseroptek Co., Ltd. | GEX | Class II | 2022-06-09 |
| K221371 | Promisemed Heel Blood Lancet | Promisemed Hangzhou Meditech Co., Ltd. | FMK | Class II | 2022-06-08 |
| K211207 | Diacare 7000 | Globus Sport and Health Technologies, LLC | PBX | Class II | 2022-06-06 |
| K221222 | Surgical Face Mask (HNFM0304) | Shanghai Hua EN Industrial Co, Ltd. | FXX | Class II | 2022-06-06 |
| K213332 | Multifrax Laser System | Paradigm Medical Corporation | ONG | Class II | 2022-06-03 |
| K220665 | Surgical Gown, Blue, Sterile; Surgical Gown, Blue, Non-Sterile | Excellent Medical Technology Group Co., Ltd. | FYA | Class II | 2022-06-03 |
| K220633 | MICROLET NEXT lancing device, MICROLET Lancet | Ascensia Diabetes Care U.S., Inc. | QRL | Class II | 2022-06-03 |
| K210084 | SILKRO | Hironic Co., Ltd. | GEI | Class II | 2022-06-03 |
| K220927 | IPL Hair Removal | Shenzhen Qiaochengli Technology Co., Ltd. | OHT | Class II | 2022-06-02 |
| K213261 | EpilME | Neauvia North America | GEX | Class II | 2022-06-02 |
| K214049 | Leaseir MHR Xcell | Leaseir Technologies, Slu | GEX | Class II | 2022-06-02 |
| K210107 | Genadyne UNO Plus (UNO+) Negative Pressure Wound Therapy System | Genadyne Biotechnologies, Inc. | OMP | Class II | 2022-06-01 |
| K221002 | IPL Hair Removal Device, Model(s): UI04A, UI04B, UI04C | Shenzhen Ulike Smart Electronics Co., Ltd. | OHT | Class II | 2022-06-01 |
| K211571 | Small Foam Kit, Medium Foam Kit, Large Foam Kit, Extra Large Foam Kit | Zhejiang Longterm Medical Technology Co., Ltd. | OMP | Class II | 2022-05-31 |
| K214074 | Latex Powder Free Surgical Glove with Protein Labeling Claim of 50 Microgram or Less per Gram of Glove and Tested for Use with Chemotherapy Drugs | Hartalega NGC Sdn. Bhd. | KGO | Class I | 2022-05-26 |
| K220597 | Disposable Surgical Face Mask (FM-34EE,FM-44EE) | Qingdao Bestex Rubber & Plastic Products Co., Ltd. | FXX | Class II | 2022-05-26 |
| K213039 | Micro-current facial cold and hot service (model: TPML-100) | Li-Tek Electronics Technology C0., Ltd. | OLP | Class II | 2022-05-25 |
| K220481 | Remanufactured LigaSure Exact Dissector, Without Nano-coating (LF2019) | Stryker Sustainability Solutions | GEI | Class II | 2022-05-25 |
| K220793 | InnoVoyce Laser Fiber | Innovoyce, LLC | GEX | Class II | 2022-05-25 |
| K211652 | Renuvion Dermal Handpiece, Renuvion Dermal System | Apyx Medical Corporation (Formerly Bovie Medical Corporation | GEI | Class II | 2022-05-25 |
| K211953 | Disposable Sterilized Latex Surgical Gloves | Jiangxi Kemei Medical Apparatus & Instruments Group Co., Ltd. | KGO | Class I | 2022-05-25 |
| K220191 | Disposable Face Mask | Jiujiang Taixin Technology Co., Ltd. | FXX | Class II | 2022-05-24 |
16,323 clearances in the General, Plastic Surgery panel. Data: openFDA.