Predicate Research Report · generated 2026-08-21 · Print / save as PDF · Save to account
General, Plastic Surgery — Predicate Candidate Screening
16,262 FDA 510(k) clearances under this medical specialty; the 50 most recent screened below.
114 daysmedian FDA review time
317 days90th percentile
2,000clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K261028 | Surgical Gown Level2 (S, M, L, XL, XXL, XXXL) | Yadu Medical (Henan) Co., Ltd. | 2026-08-07 | 130 | 0 |
| K261601 | LED Light Therapy Mask (M01, M02, M03, M05, M06, M07, M08) | Shenzhen Chuangtong Yigou Technology Co., Ltd. | 2026-08-07 | 85 | 0 |
| K261496 | LED Light Therapy Masks (PE748, PE749, PE756) | Duplex International Trading Limited | 2026-08-04 | 90 | 0 |
| K261851 | LED Light Therapy Mask (JML1, JML1+JML2); LED Light Therapy | Shenzhen Qianyu Technology Co., Ltd. | 2026-08-04 | 62 | 0 |
| K261503 | PuraStat GI | 3-D Matrix, Inc. | 2026-08-03 | 89 | 0 |
| K261482 | LightStim for Wrinkles (1984); LightStim for Acne (2038) | Led Intellectual Properties, LLC | 2026-07-31 | 87 | 0 |
| K260558 | Latex Powder Free Surgical Gloves Tested for Use with Chemot | Hartalega NGC Sdn. Bhd. | 2026-07-28 | 159 | 0 |
| K260598 | 5 Wavelength LED Facemask (TN2508) | iSMART Developments, Ltd. | 2026-07-24 | 150 | 0 |
| K261221 | SOLTIVE™ Laser System (SOLTIVE™ Pro SuperPulsed Laser, SOLTI | Olympus Surgical Technologies America | 2026-07-24 | 101 | 0 |
| K262211 | Lancet | Tianjin Huahong Technology Co., Ltd. | 2026-07-22 | 22 | 0 |
| K260804 | Anovo Surgical System (6Ne) | Momentis Surgical , Ltd. | 2026-07-22 | 132 | 0 |
| K261179 | AlphaTriPart - Monopolar MIC Instruments | Gimmi GmbH | 2026-07-22 | 103 | 0 |
| K261738 | Medical Thulium Fiber Laser Systems (UroFiber 150Q) | Rhein Laser Technologies Co., Ltd. | 2026-07-21 | 55 | 0 |
| DEN250068 | OTTAVA™ Robotic Surgical System | Auris Health, Inc., part of Johnson & Johnson MedTech | 2026-07-21 | 215 | 0 |
| K254231 | Inno-Hook™ Disposable Clip Appliers (Ligating Clips) and Inn | Taiwan Surgical Corporation | 2026-07-20 | 203 | 0 |
| K261693 | Diode laser hair removal machine (QDTM-04) | Beijing Nubway S&T Co., Ltd. | 2026-07-17 | 56 | 0 |
| K261674 | Skin Air Cooling System (QALF-01) | Beijing Nubway S&T Co., Ltd. | 2026-07-16 | 56 | 0 |
| K261407 | XPREEN LED Light Therapy Masks (XPRE322, XPRE326, XPRE327, X | Dongguan Miqiang Technology Co., Ltd. | 2026-07-15 | 77 | 0 |
| K253504 | Volnewmer™ | Classys, Inc. | 2026-07-13 | 255 | 0 |
| K261949 | NYES Tuff Cuff L3 Disposable Gowns | New York Embroidery Studio | 2026-07-10 | 29 | 0 |
| K261978 | WallFlex Esophageal Stent System;Agile Esophageal Over-the-W | Boston Scientific Corporation | 2026-07-10 | 28 | 0 |
| K253480 | Capenergy C Equipments RF C200 and C400 Drakarian | Capenergy Medical S.L. | 2026-07-10 | 269 | 0 |
| K260723 | HYDROS Robotic System (HY1000);HYDROS Handpiece (HH1000);HYD | Procept Biorobotics | 2026-07-09 | 126 | 0 |
| K261988 | Monodek™ (POLYDIOXANONE) Dyed Violet Monofilament Synthetic | Teleflex Medical, LLC | 2026-07-09 | 27 | 0 |
| K260122 | Lancing Device (PressGo, LDE3, LDE3AST, LDE5, EasyStep) | SteriLance Medical (Suzhou), Inc. | 2026-07-06 | 172 | 0 |
| K261473 | Chromix | Termosalud S.L. | 2026-07-01 | 58 | 0 |
| K254056 | THUNDERBEAT 5 mm, 45 cm, Front-actuated Grip Type S (TB-0545 | Olympus Medical Systems Corp. | 2026-07-01 | 196 | 0 |
| K261021 | EasyWhip Family | Winter Innovations, Inc. | 2026-07-01 | 96 | 0 |
| K261068 | Maverix Cryo Biopsy Probe (MCB1000);Maverix Cryo Cartridge ( | Serpex Medical | 2026-06-30 | 90 | 0 |
| K253484 | LUTRONIC GENIUS | Cynosure Lutronic Technology Corporation | 2026-06-29 | 255 | 0 |
| K261052 | LED Light Therapy Masks (LED Face Mask Pro FAC08NA, LED Ches | Guangdong Newdermo Biotech Co., Ltd. | 2026-06-29 | 90 | 0 |
| K251492 | Irrigation Tubing Bipolar Cord Set | New Deantronics Taiwan , Ltd. | 2026-06-29 | 410 | 0 |
| K254232 | ECLIPTIS Left Atrial Appendage Exclusion System (ECS135); EC | Edwards Lifesciences | 2026-06-26 | 179 | 0 |
| K253394 | Coated VICRYL™ (Polyglactin 910) Plus Antibacterial Suture | ETHICON, Inc. | 2026-06-25 | 268 | 0 |
| K253263 | ConvaVAC™ Negative Pressure Wound Therapy System | Convatec Limited, Gdc Building | 2026-06-24 | 268 | 0 |
| K253199 | CURASYS 2 (EMDN0003) | CG Bio Co., Ltd. | 2026-06-23 | 270 | 0 |
| K253211 | AQUABEAM Robotic System | Procept Biorobotics | 2026-06-23 | 267 | 0 |
| K260946 | LED Light Therapy Mask (K9C-TK, K9C-K, K9P-YK, K9P-K, FM-03B | Guangdong Newdermo Biotech Co., Ltd. | 2026-06-18 | 87 | 0 |
| K261701 | Hemolase Fiber (Hemo-R-0.40-2.5/Hemo-R-0.60-2.5/Hemo-R-0.40- | Micro-Energy Medical Technology Co., Ltd. | 2026-06-18 | 27 | 0 |
| K260636 | Remanufactured LigaSure XP Maryland Jaw Sealer/Divider Witho | Stryker Sustainability Solutions | 2026-06-18 | 112 | 0 |
| K261570 | PICOSURE WORKSTATION | Cynosure, LLC | 2026-06-17 | 36 | 0 |
| K253634 | CoolSeal Generator® (CSL-200-90) | Hologic, Inc. | 2026-06-17 | 210 | 0 |
| K261833 | NEUROMARK System (NMK00301) | Neurent Medical , Ltd. | 2026-06-16 | 14 | 0 |
| K254025 | LED Neck Beauty Mask (ZLD-66A,ZLD-90E,ZLD-130,ZLD-180H) | Shenzhen Kaiyan Medical Equipment Co., Ltd. | 2026-06-16 | 182 | 0 |
| K261634 | Disposable Blood Lancet (Soft) | SteriLance Medical (Suzhou), Inc. | 2026-06-12 | 25 | 0 |
| K252171 | Barbed PDO Suture | Sutura Medical Technology, Inc. | 2026-06-12 | 337 | 0 |
| K261204 | Intense Pulsed Light Therapy Device | Sanhe LEFIS Electronics Co., Ltd. | 2026-06-12 | 60 | 0 |
| K260653 | Dexter L6 System | Distalmotion SA | 2026-06-11 | 104 | 0 |
| K261621 | TekBrace Solo Soft Tissue Reinforcement Device | Theramicro | 2026-06-09 | 25 | 0 |
| K253165 | LAP-iX2N | Sejong Medical Co., Ltd. | 2026-06-09 | 256 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda