Review Panel
General, Plastic Surgery FDA 510(k) Clearances & Devices
- Cleared Devices
- 16,323
- Product Codes (page)
- 37
- Latest Decision
- 2025-02-27
Clearances · page 7 of 164
| K-Number | Trade Name | Applicant / Manufacturer | Product Code | Class | Decision Date |
|---|---|---|---|---|---|
| K242175 | XOD Diathermia Radiofrequency Device | Xod, Inc. | PBX | Class II | 2025-02-27 |
| K244031 | Disposable Blood Lancet (Soft Pro); Disposable Blood Lancet (Softsure); Disposable Blood Lancet (Softsure Pro); Disposable Blood Lancet (Softsense) | SteriLance Medical (Suzhou), Inc. | QRK | Class II | 2025-02-26 |
| K244036 | Heel Incision Safety Lancet (SteriHeel 2) | SteriLance Medical (Suzhou), Inc. | FMK | Class II | 2025-02-26 |
| K243918 | Vasoview Hemopro 3 Power Supply | Maquet Cardiovascular, LLC | GEI | Class II | 2025-02-26 |
| K242844 | Medline Level 4 Surgical Gown with Breathable Sleeves | Medline Industries, LP | FYA | Class II | 2025-02-26 |
| K250281 | DEKA LOTUS | El.En S.P.A. | ONF | Class II | 2025-02-26 |
| K243276 | ECHELON LINEAR Stapler 30mm Stapler (GTX30); ECHELON LINEAR Stapler 60mm Stapler (GTX60); ECHELON LINEAR Stapler 90mm Stapler (GTX90); ECHELON LINEAR Stapler 3D 30mm Blue Reload (GTXR30B); ECHELON LINEAR Stapler 3D 30mm Green Reload (GTXR30G); ECHELON LINEAR Stapler 3D 60mm Blue Reload (GTXR60B); ECHELON LINEAR Stapler 3D 60mm Green Reload (GTXR60G); ECHELON LINEAR Stapler 3D 90mm Blue Reload (GTXR90B); ECHELON LINEAR Stapler 3D 90mm Green Reload (GTXR90G) | Ethicon Endo-Surgery, LLC | GDW | Class II | 2025-02-25 |
| K243035 | Ulthera® System | Ulthera, Inc. | OHV | Class II | 2025-02-24 |
| K243330 | LYMA Laser PRO | Lyma Life , Ltd. | OHS | Class II | 2025-02-21 |
| K234004 | Medical diode laser systems (CHARISMA, REGAL) | Reveal Lasers , Ltd. | GEX | Class II | 2025-02-20 |
| K243588 | Single Use CO2 Laser Fiber (HAF005001) | Quanta System Spa | GEX | Class II | 2025-02-19 |
| K243241 | Phasix ST Umbilical Hernia Patch | Davol, Inc., A Subsidiary of C.R. Bard, Inc. | OWT | Class II | 2025-02-19 |
| K243576 | RENASYS Foam Wound Dressing Kit with AIRLOCK Technology and Soft Port; RENASYS Gauze Wound Dressing Kit with AIRLOCK Technology and Soft Port | Smith & Nephew Medical, Ltd. | OMP | Class II | 2025-02-18 |
| K242593 | CurrentBody LED 4 in 1 Zone Facial Mapping Mask (MK-90C, MK-90M, MK66RB-F, MK-90N) | Shenzhen Kaiyan Medical Equipment Co., Ltd. | OHS | Class II | 2025-02-14 |
| K241527 | Pastelle Pro | Wontech Co., Ltd. | GEX | Class II | 2025-02-14 |
| K241643 | WONTECH Surgical Optic Fibers (BA400/BA400R/BA600/BA600R) | Wontech Co., Ltd. | GEX | Class II | 2025-02-14 |
| K241832 | Unicorn+ RF System (Unicorn+); Unicorn+ RF System (Unicorn+ I); Unicorn+ RF System (Unicorn+ II); Unicorn+ RF System (Unicorn+ III) | Boston Aesthetics, Inc. | GEI | Class II | 2025-02-13 |
| K250200 | InbellaBody System | Inbella Medical, Inc. | GEI | Class II | 2025-02-11 |
| K243453 | Philips Lumea IPL | Philips Consumer Lifestyle B.V. | OHT | Class II | 2025-02-10 |
| K242368 | Symani Surgical System | Medical Microinstruments, Inc. | SAQ | Class II | 2025-02-07 |
| K243780 | HELIOS 785 Pico (1754V2) | Laseroptek Co., Ltd. | GEX | Class II | 2025-02-07 |
| K243465 | Diode Laser Hair Removal Device (EVOLUTION MEDICAL); Diode Laser Hair Removal Device (M-I-X MEDICAL); Diode Laser Hair Removal Device (GENESIS); Diode Laser Hair Removal Device (Lotus); Diode Laser Hair Removal Device (Ultimate) | Guangzhou Chuang Zao Mei Technology Co., Ltd. | GEX | Class II | 2025-02-06 |
| K242977 | 308nm Excimer Phototherapy Device (CN-308E, KN-4003B3, KN-4003B4, KN-5000C KN-5000D, KN-5000H, KN-5000K) | Xuzhou Kernel Medical Equipment Co., Ltd. | FTC | Class II | 2025-02-06 |
| K242983 | CROMA Electrosurgical Generator (PRD-EMR-050) | Creo Medical, Ltd. | GEI | Class II | 2025-02-05 |
| K243555 | LED light therapy mask (E43, E32, E49B, E49C, E100B, E100C, E103B, E104B, E106A, E108A) | Shenzhen Eyco Technology Co., Ltd. | OLP | Class II | 2025-02-05 |
| K250068 | Venclose digiRF Generator (VCRFG1) | Venclose, Inc. | GEI | Class II | 2025-02-04 |
| K243138 | Geon (S2) Nasal Aspirator | Geon Corporation | BTA | Class II | 2025-02-04 |
| K243182 | Anovo Instrument ARM Curved Scissors; Anovo Instrument ARM Hook Electrode | Momentis Surgical , Ltd. | QNM | Class II | 2025-02-03 |
| K241270 | BTL-754 | BTL Industries, Inc. | GEX | Class II | 2025-01-30 |
| K243213 | Self-Forming Magnet (FLEX SFM) | GI Windows, Inc. | SAH | Class II | 2025-01-29 |
| K243042 | Co-Ablation System with Sterile Co-Ablation Probe | Hygea Medical Technology Co., Ltd. | GEH | Class II | 2025-01-29 |
| K243423 | LED Light Therapy Mask (Model(s): RB-008, RB-030, RB-081, RB-008G, RB-008GB, RB-008J, RB-008JB) | Shenzhen Rainbow Technology Co., Ltd. | OHS | Class II | 2025-01-28 |
| K242941 | CO2 Laser Therapy Systems (SHE-LSP003-1) | Beijing Sano Laser S&T Development Co.,Ltd | GEX | Class II | 2025-01-27 |
| K250014 | Symani Surgical System (820-03830) | Medical Microinstruments, Inc. | SAQ | Class II | 2025-01-27 |
| K241107 | Indiba Diathermia Radiofrequency Deep Care Device (Deep care IDC0409/EVONY ); Indiba Diathermia Radiofrequency Activ Device (Activ ACT0309/CT9) | Indiba S. A. U. | PBX | Class II | 2025-01-24 |
| K242835 | Suture-TOOL System | Suturion AB | NEW | Class II | 2025-01-22 |
| K240311 | JETT Medical II | Compex, Spol, S.R.O. | GEI | Class II | 2025-01-22 |
| K243139 | Reverso Pro System | Indiba S. A. U. | GEI | Class II | 2025-01-22 |
| K243929 | Oligio X | Wontech Co., Ltd. | GEI | Class II | 2025-01-21 |
| K242288 | Advanced Cryo Wart Remover | Medical Brands Laboratories B.V. | GEH | Class II | 2025-01-21 |
| K243067 | The ETHICON Total Energy System | Ethicon Endo-Surgery, LLC (A Johnson and Johnson Company) | GEI | Class II | 2025-01-17 |
| K243315 | ProGrip Self-Gripping Polypropylene Mesh | Sofradim Production | FTL | Class II | 2025-01-17 |
| K243860 | AtriClip PRO-Mini LAA Exclusion System (PROM) | AtriCure, Inc. | PZX | Class II | 2025-01-15 |
| K242541 | GEM ZIPCLIP | Synovis Micro Companies Alliance A Subsidiary of Baxter Int | FZP | Class II | 2025-01-15 |
| K242689 | AAMI Level 4 Protective; Gown | Azac Group | QPC | Class II | 2025-01-13 |
| K243533 | Sterilized Eol Auto Lancet; Sterilized Eol Lancet Plus | Hlb Co., Ltd. Healthcare | FMK | Class II | 2025-01-13 |
| K242680 | LetsGetChecked Impress | Privapath Diagnostics Ltd (Dba Letsgetchecked) | FMK | Class II | 2025-01-13 |
| K243492 | Ulike Reglow Light Therapy Device (UM10) | Shenzhen Ulike Smart Electronics Co., Ltd. | OHS | Class II | 2025-01-10 |
| K243811 | Erchonia Zerona® VZ8 | Erchonia Corporation | OLI | Class II | 2025-01-10 |
| K233118 | DUET-V (Model: ESK-3261DV) | Eunsung Global Corp | GEI | Class II | 2025-01-03 |
| K243737 | Inbella RF System | Inbella Medical, Inc. | GEI | Class II | 2025-01-03 |
| K242789 | Bestqool LED Therapy Device (LMK-001,LMK-004,LMK-005,LMK-006) | Dongguan Laiguang Electronic Technology Co., Ltd. | OHS | Class II | 2025-01-02 |
| K241852 | Nasal Aspirator (NS 13) | Avita Corporation | BTA | Class II | 2024-12-31 |
| K242804 | PAL Aspiration System | Microaire Surgical Instruments, LLC | QPB | Class II | 2024-12-30 |
| K243445 | Splendor X (Alex, Alex2, Nd:YAG, Alex+Nd:YAG) | Bios S.R.L. | GEX | Class II | 2024-12-30 |
| K232966 | FISIOWARM 7.0 | Golden Star Srl | PBX | Class II | 2024-12-26 |
| K243037 | Diode Laser System model Dawn-S | Shanghai Wonderful Opto-Electrics Tech.Co.,Ltd | GEX | Class II | 2024-12-26 |
| K243141 | Diode Laser System (LaserPro D 980); Diode Laser System (LaserPro D 810); Diode Laser System (Aurolance 980); Diode Laser System (Aurolance 810); Diode Laser System (Aurolance AM) | Jiangxi Medex Technology Co., Ltd. | GEX | Class II | 2024-12-26 |
| K243097 | RM STAR EX with RMS Needle | Bomtech Electronics Co., Ltd. | GEI | Class II | 2024-12-26 |
| K240975 | Electrosurgical Generator (ES-100); Electrosurgical Generator (ES-300) | Beijing Taktvoll Technology Co., Ltd. | GEI | Class II | 2024-12-23 |
| K233614 | Genadyne DUO NPWT | Genadyne Biotechnologies, Inc. | OMP | Class II | 2024-12-23 |
| K243121 | SLT Select Fiber Delivery System and Contact Tips (models: SSRH 8-SMA; TCRH 7-SMA; FEF 2.2-SMA; CFE 0.6-SMA; SSRH 8Z-SMA; SSRH 4-SMA; SSRH 6-SMA; SSRH 9-SMA; SSRH 10-SMA; SSRH 11-SMA; SSRH 7L-SMA; TCRH 7Z-SMA; FEF 1.8-SMA; CFE 0.55-SMA; CFE 0.36-SMA; LAL 550-SMA; LAL 550Z-SMA; LAL 365-SMA; LAL 365Z-SMA; ER2; ERP2; GR2; GRP2; ER4; ERP4; GR4; GRP4; ER6; ERP6; GR6; GRP6; ER8; ERP8; GR8; GRP8; ER10; ERP10; GR10; GRP10; ER12; ERP12; GR12; GRP12; MD2.5; MD3.5; HP1.0; MTP1.5; MTP3.5; MTRG1.5; | Jiangxi Medex Technology Co., Ltd. | GEX | Class II | 2024-12-22 |
| K243147 | LGO-Surgical Laser Fibers | Light Guide Optics International , Ltd. | GEX | Class II | 2024-12-21 |
| K243085 | IPL Hair Removal Device (DE03A-W, DE03A-P, DE03A-V, DE03A-G, DE03B-W, DE03B-P, DE03B-V, DE03B-G) | Zhuzhou Goldenhot Medical Technology Co., Ltd. | OHT | Class II | 2024-12-21 |
| K241670 | Fractional CO2 Laser Therapy System (FG900-S); Fractional CO2 Laser Therapy System (FG900-S2) | Beijing Adss Development Co., Ltd. | GEX | Class II | 2024-12-20 |
| K233639 | SmartClip Secure Soft Tissue Marker | Elucent Medical, Inc. | NEU | Class II | 2024-12-20 |
| K243040 | LED Light Therapy Mask (SKB-1818P,SKB-1918,SKB-1918P,SKB-1918PLUS,SKB-2318L,SKB-2318P,SKB-2318PRO,IN-FM002, SKB-2418) | Shenzhen Siken 3D Technology Development Co., Ltd. | OHS | Class II | 2024-12-20 |
| K242688 | Finiff System | Skingrab Co., Ltd. | GEI | Class II | 2024-12-20 |
| K242534 | HandPICO Fractional Laser Handpiece Tip | Vydence Medical | GEX | Class II | 2024-12-20 |
| K242908 | UV Phototherapy Device (Group A: SQ308PCHFD, SQ308PCQFD, SQ308PCPFD, SQ308PCNFD, SQ308PCMFD); UV Phototherapy Device (Group B: SQ308PHTFF, SQ308PHSFF, SQ308PHRFF, SQ308PHZFG, SQ308PPUFF, SQ308PPVFF, SQ308PPWFG) | Shanghai Sigma High-Tech Co., Ltd. | FTC | Class II | 2024-12-19 |
| K243595 | OviTex PRS (Long-Term Resorbable) | TELA Bio, Inc. | FTM | Class II | 2024-12-19 |
| K242700 | Radiant Renewal Skincare Lid (HD-59A, HD-59B, HD-59C, HD-59D, HD-70, HD-72, HD-72A, HD-73A, HD-73B, HD-116, HD-116A, HD-53A, HD-53B) | Shenzhen Nuon Medical Equipment Co., Ltd. | OHS | Class II | 2024-12-19 |
| K242370 | Medline Microdissection Needle (4cm) (140936 (ESE104A)); Medline Microdissection Needle (3cm) (140937 (ESE103A)) | Medline Industries, LP | GEI | Class II | 2024-12-19 |
| K242987 | Thulium Fiber Laser (FiberLAZE+, FiberLAZE) | Allengers Global Healthcare Private Limited | GEX | Class II | 2024-12-17 |
| K241998 | Ice Cooling IPL Hair Removal Device (UI20 DB, UI20 RE, UI20 GP, UI20 PW, UI20S DB, UI20S RE, UI20S PW, UI20S GP,UI20 WH, UI20 GR, UI20 BS, UI20 MP, UI20 BL, UI20 PN, UI20 BR, UI20WG, UI20S WH, UI20S GR, UI20S BS, UI20S MP) | Shenzhen Ulike Smart Electronics Co., Ltd. | OHT | Class II | 2024-12-13 |
| K241253 | Medicon Epiplating System | Cmf Medicon Surgical, Inc. | FZE | Class II | 2024-12-12 |
| K240758 | Radiofrequency Generator System, Cura RF Electrode | Zhejiang Curaway Medical Technology Co., Ltd. | GEI | Class II | 2024-12-11 |
| K241219 | FiberLocker System: FiberLocker Implant (SpeedPatch PET), FiberLocker Instrument (FiberLocker Instrument SN) | ZuriMED Technologies AG | OWX | Class II | 2024-12-11 |
| K242630 | Aerin Console | Aerin Medical, Inc. | GEI | Class II | 2024-12-10 |
| K231216 | POTENZA | Jeisys Medical, Inc. | GEI | Class II | 2024-12-10 |
| K242710 | Hair Removal Device (R3C16-P, R3C16-W, R3C16-G, R3C16-P Pro, R3C16-W Pro, R3C16-G Pro, R3505-W, R3505-B, R3505-W Pro, R3505-B Pro) | Shenzhen Jianchao Intelligent Technology Co., Ltd. | OHT | Class II | 2024-12-06 |
| K242687 | NanoKnife Generator (H78720300301US0); NanoKnife Single Electrode Activation Probe, 15 cm (H787204001090); NanoKnife Single Electrode Activation Probe, 25 cm (H787204001100); NanoKnife Single Electrode Probe Spacer (H787204003010) | AngioDynamics, Inc. | OAB | Class II | 2024-12-06 |
| K243454 | Verruca-Freeze H | Cryosurgery, Inc. | GEH | Class II | 2024-12-03 |
| K241486 | Sofsilk Coated Braided Silk Suture | Covidien | GAP | Class II | 2024-12-03 |
| K243418 | Riptide Aspiration Pump; Riptide Collection Canister with Intermediate Tubing | Micro Therapeutics, Inc. d/b/a ev3 Neurovascular | JCX | Class II | 2024-12-02 |
| K240994 | Nexpowder | Nextbiomedical Co., Ltd. | QAU | Class II | 2024-11-27 |
| K243362 | SmoothSkin Pure Switch (SSC1) | Cyden Limited | OHT | Class II | 2024-11-27 |
| K242187 | BioBrace® | Conmed Corporation | OWW | Class II | 2024-11-27 |
| K241835 | AirSculpt Body Contouring System (AIRS-1-SYS) | Cellmyx | QPB | Class II | 2024-11-27 |
| K242796 | CryoGlow (FW3XXXX) | Sharkninja Operating, LLC | OHS | Class II | 2024-11-27 |
| K242638 | LED Light Therapy Machine (G1, G3, G4, G6) | Shenzhen Walton Technology Co., Ltd. | OHS | Class II | 2024-11-27 |
| K240897 | Cellinew | VIOL Co., Ltd. | GEI | Class II | 2024-11-26 |
| K242631 | REGENETEN Bioinductive Implant | Smith & Nephew Inc., Endoscopy Div. | OWY | Class II | 2024-11-26 |
| K242553 | MIRARI® Cold Plasma System ( GV-M2-01) | General Vibronics, Inc. | PBX | Class II | 2024-11-21 |
| K241157 | Secret MAX Multi-platform RF System | Ilooda Co,., Ltd. | GEI | Class II | 2024-11-21 |
| K243164 | INDIBA COMPACT devices | Indiba S. A. U. | PBX | Class II | 2024-11-20 |
| K242028 | Nasal Aspirator (BC-021, BC-022, BC-023, BC-024, BC-025, BC-026) | Dongguanshi Yiyingmei Technology Co., Ltd. | BTA | Class II | 2024-11-19 |
| K242293 | Medical Thulium Fiber Laser Systems (UroFiber 60Q) | Rhein Laser Technologies Co., Ltd. | GEX | Class II | 2024-11-19 |
| K241498 | Diode laser Treatment System (K18) | Hebei Keylaser Sci-Tech Co.,Ltd | GEX | Class II | 2024-11-18 |
| K241138 | ArtiSeal Vessel Sealing System-ArtiSeal Instruments; ArtiSeal Vessel Sealing System-ArtiSeal Generator | Livsmed, Inc. | GEI | Class II | 2024-11-15 |
16,323 clearances in the General, Plastic Surgery panel. Data: openFDA.