FDA Product Code
FDA Product Code GEX — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- General, Plastic Surgery
- 21 CFR Citation
- 878.4810
510(k) Clearances — 2,887 records · page 2 of 29
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K250782 | Fractional CO2 Laser Machine | Zhengzhou PZ Laser Slim Technology Co., Ltd. | 2025-06-12 | Traditional | PDF ↗ |
| K250936 | Q-Switched Nd:YAG Laser (SHE-LSP101-1) | Beijing Sano Laser S&T Development Co.,Ltd | 2025-06-12 | Traditional | PDF ↗ |
| K243683 | Deka Bluebeam | El.En S.P.A. | 2025-06-12 | Traditional | PDF ↗ |
| K250465 | CO2 Laser Machine (Lume) | Nanjing Bestview Laser S&T Co., Ltd. | 2025-06-09 | Traditional | PDF ↗ |
| K240983 | Discovery Pico; Discovery Pico Plus; Discovery Pico Derm | Quanta System Spa | 2025-06-06 | Traditional | PDF ↗ |
| K250722 | Nd: YAG Laser Therapy System (QN-1) | Hebei JT Medical Co., Ltd. | 2025-06-06 | Traditional | PDF ↗ |
| K250195 | MateLaser Medical Laser Therapy Systems (ML-HIL-30, ML-HIL-60) | Matelaser, Inc. | 2025-05-30 | Traditional | PDF ↗ |
| K251230 | The Alma Hybrid Laser System | Alma Lasers, Inc. | 2025-05-21 | Special | PDF ↗ |
| K250041 | Medical Picosecond ND: YAG Laser System (PZ-6) | Zhengzhou PZ Laser Slim Technology Co., Ltd. | 2025-05-14 | Traditional | PDF ↗ |
| K251288 | Veincare | Wontech Co., Ltd. | 2025-05-14 | Special | PDF ↗ |
| K250431 | Medical Diode Laser Hair Removal System (MNLT-D1) | Shandong Moonlight Electronics Tech Co., Ltd. | 2025-05-12 | Traditional | PDF ↗ |
| K251094 | Alma Veil | Wontech Co., Ltd. | 2025-05-06 | Special | PDF ↗ |
| K242951 | Diode laser hair removal machine (QDTM-02) | Beijing Nubway S&T Co., Ltd. | 2025-04-28 | Traditional | PDF ↗ |
| K250206 | Diode laser system (Night Universe; Predator) | Ivylaser (Beijing) Technology Co.,Ltd | 2025-04-24 | Traditional | PDF ↗ |
| K250183 | CO2 Laser System (CO2 Laser SST-L23) | Zhuozhou Summer Star Technologies Co., Ltd. | 2025-04-24 | Traditional | PDF ↗ |
| K250809 | Stellar M22 | Lumenis Be, Ltd. | 2025-04-16 | Special | PDF ↗ |
| K243044 | Alma Harmony | Alma Lasers, Inc. | 2025-04-11 | Traditional | PDF ↗ |
| K250656 | Medical Diode Laser (Models: MZ-GK, MZ-K20, MZ-N75) | Wuhan Pioon Technology Co., Ltd. | 2025-04-04 | Special | PDF ↗ |
| K250018 | Medical Diode Laser Systems (THEIA808) | Gigaalaser Company , Ltd. | 2025-04-01 | Traditional | PDF ↗ |
| K250189 | AdvaTx | Advalight Aps | 2025-04-01 | Traditional | PDF ↗ |
| K243630 | Medical Laser System Incanto / Evoline Platinum /Evoline | Solar LS Cjsc | 2025-03-21 | Traditional | PDF ↗ |
| K241791 | Medical Diode Laser Systems (GBOX-6H, GBOX-10D , GBOX-12D, GBOX-15D, VELAS Pro-30B15D, VELAS II-6H, VELAS II-15D) | Gigaalaser Company , Ltd. | 2025-03-19 | Traditional | PDF ↗ |
| K250113 | neoLaser Laser Surgery Fibers | G.N.S Neolaser , Ltd. | 2025-03-13 | Traditional | PDF ↗ |
| K243993 | Photon Therapy Apparatus (BL-10) | Xemis Medical Technology (Shenzhen) Co., Ltd. | 2025-03-13 | Traditional | PDF ↗ |
| K243957 | PICOALEX | Wontech Co., Ltd. | 2025-03-12 | Traditional | PDF ↗ |
| K242207 | NOABLE LASER | Daeju Meditech Engineering Co., Ltd. | 2025-03-07 | Traditional | PDF ↗ |
| K242943 | Q Switched Nd:YAG Laser machine (QNHF-01) | Beijing Nubway S&T Co., Ltd. | 2025-03-03 | Traditional | PDF ↗ |
| K234004 | Medical diode laser systems (CHARISMA, REGAL) | Reveal Lasers , Ltd. | 2025-02-20 | Traditional | PDF ↗ |
| K243588 | Single Use CO2 Laser Fiber (HAF005001) | Quanta System Spa | 2025-02-19 | Traditional | PDF ↗ |
| K241527 | Pastelle Pro | Wontech Co., Ltd. | 2025-02-14 | Traditional | PDF ↗ |
| K241643 | WONTECH Surgical Optic Fibers (BA400/BA400R/BA600/BA600R) | Wontech Co., Ltd. | 2025-02-14 | Traditional | PDF ↗ |
| K243780 | HELIOS 785 Pico (1754V2) | Laseroptek Co., Ltd. | 2025-02-07 | Traditional | PDF ↗ |
| 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. | 2025-02-06 | Traditional | PDF ↗ |
| K241270 | BTL-754 | BTL Industries, Inc. | 2025-01-30 | Traditional | PDF ↗ |
| K242941 | CO2 Laser Therapy Systems (SHE-LSP003-1) | Beijing Sano Laser S&T Development Co.,Ltd | 2025-01-27 | Traditional | PDF ↗ |
| K243445 | Splendor X (Alex, Alex2, Nd:YAG, Alex+Nd:YAG) | Bios S.R.L. | 2024-12-30 | Traditional | PDF ↗ |
| K243037 | Diode Laser System model Dawn-S | Shanghai Wonderful Opto-Electrics Tech.Co.,Ltd | 2024-12-26 | Traditional | PDF ↗ |
| 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. | 2024-12-26 | Traditional | PDF ↗ |
| 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. | 2024-12-22 | Traditional | PDF ↗ |
| K243147 | LGO-Surgical Laser Fibers | Light Guide Optics International , Ltd. | 2024-12-21 | Traditional | PDF ↗ |
| K241670 | Fractional CO2 Laser Therapy System (FG900-S); Fractional CO2 Laser Therapy System (FG900-S2) | Beijing Adss Development Co., Ltd. | 2024-12-20 | Traditional | PDF ↗ |
| K242534 | HandPICO Fractional Laser Handpiece Tip | Vydence Medical | 2024-12-20 | Traditional | PDF ↗ |
| K242987 | Thulium Fiber Laser (FiberLAZE+, FiberLAZE) | Allengers Global Healthcare Private Limited | 2024-12-17 | Traditional | PDF ↗ |
| K242293 | Medical Thulium Fiber Laser Systems (UroFiber 60Q) | Rhein Laser Technologies Co., Ltd. | 2024-11-19 | Traditional | PDF ↗ |
| K241498 | Diode laser Treatment System (K18) | Hebei Keylaser Sci-Tech Co.,Ltd | 2024-11-18 | Traditional | PDF ↗ |
| K241930 | Veincare | Wontech Co., Ltd. | 2024-11-14 | Traditional | PDF ↗ |
| K241646 | ORTIV (ORTIV-BL, ORTIV-WH) | Mvitro Co., Ltd. | 2024-11-01 | Traditional | PDF ↗ |
| K240543 | Rapido Medical Laser (Rapido MED, Rapido Derma, Rapido ENT, Rapido Podia) | Medency S.R.L. | 2024-10-24 | Traditional | PDF ↗ |
| K242183 | Fractional CO2 Laser Therapy System (EXFU CO2) | Weifang Mingliang Electronics Co., Ltd. | 2024-10-23 | Traditional | PDF ↗ |
| K242132 | FREDDO | Fabinject Lndustria E Comercio Lmportacao E Exportacao Ltda | 2024-10-18 | Traditional | PDF ↗ |
| K242035 | Accure Laser System | Accure Acne, Inc. | 2024-10-11 | Traditional | PDF ↗ |
| K241951 | Lasya-Trinity | BLUECORE COMPANY Co., Ltd. | 2024-10-10 | Traditional | PDF ↗ |
| K241092 | Youlaser PRIME; Youlaser PRIME CO2; Youlaser PRIME MT | Quanta System Spa | 2024-10-10 | Traditional | PDF ↗ |
| K231948 | MEDIYAG | Medicreations, LLC | 2024-10-09 | Special | PDF ↗ |
| K242206 | ACTIVO | Daeju Meditech Engineering Co., Ltd. | 2024-09-27 | Traditional | PDF ↗ |
| K241860 | Diode Laser Hair Removal System | Beijing Winkonlaser Technology Limited | 2024-09-25 | Traditional | PDF ↗ |
| K240604 | MTONE EVO (MTONE EVO) | M&T S.R.L. | 2024-09-20 | Traditional | PDF ↗ |
| K241771 | Liftendo; Liftendo 2.0 | Medical San Indústria DE Equipamentos Médicos Ltda. | 2024-09-16 | Traditional | PDF ↗ |
| K242349 | FoLix | Lumenis Be, Ltd. | 2024-09-09 | Special | PDF ↗ |
| K241672 | COPRO 3 | Amt Engineering Co., Ltd. | 2024-09-06 | Traditional | PDF ↗ |
| K242251 | Litho 60; Litho 100; Litho 150 | Quanta System Spa | 2024-09-03 | Special | PDF ↗ |
| K242202 | LightWalker Laser System Family | Fotona D.O.O. | 2024-08-23 | Special | PDF ↗ |
| K242191 | SOLTIVE Laser System (SOLTIVE Pro SuperPulsed Laser, SOLTIVE Premium SuperPulsed Laser, SOLTIVE Laser Fibers, and Accessories) | Olympus Surgical Technologies America | 2024-08-23 | Special | PDF ↗ |
| K242142 | Fraxel® FTX Laser System | Solta Medical | 2024-08-21 | Traditional | PDF ↗ |
| K241547 | Diode Laser Therapy Device (DF-DIODE LASER-S1) | Weifang Dragonfly Electronics Technology Co., Ltd. | 2024-08-13 | Traditional | PDF ↗ |
| K241699 | SUPER VELOCE | Ilooda Co,., Ltd. | 2024-08-13 | Traditional | PDF ↗ |
| K241656 | Eneka Selectif | Termosalud | 2024-08-12 | Traditional | PDF ↗ |
| K231950 | MEDIDIODE | Medicreations, LLC | 2024-08-09 | Special | PDF ↗ |
| K241642 | Diode Laser Hair Removal System (MBT-Diode Laser) | Beijing Mega Beauty Technology Co., Ltd. | 2024-08-02 | Traditional | PDF ↗ |
| K241293 | LED Light Therapy Device, ELIXIR MD | Yassen Wellness, LLC | 2024-07-08 | Traditional | PDF ↗ |
| K241600 | Dermablate | Asclepion Laser Technologies GmbH | 2024-07-03 | Special | PDF ↗ |
| K241406 | Lavieen | Wontech Co., Ltd. | 2024-06-28 | Traditional | PDF ↗ |
| K241144 | Picosecond Nd:YAG Laser (PICOCAREMAJESTY) | Wontech Co., Ltd. | 2024-06-24 | Traditional | PDF ↗ |
| K241459 | MOTUS PRO Family | El.En S.P.A. | 2024-06-21 | Special | PDF ↗ |
| K240611 | IVYLASER Diode laser hair removal system (IVY-HR-Alloy) | Ivylaser (Beijing) Technology Co.,Ltd | 2024-06-20 | Traditional | PDF ↗ |
| K240747 | Medical Diode Laser (M2-GK) | Wuhan Pioon Technology Co., Ltd. | 2024-06-17 | Traditional | PDF ↗ |
| K241407 | Splendor X (Alex, Alex2, Nd:YAG, Alex+Nd:YAG) | Bios S.R.L. | 2024-06-14 | Traditional | PDF ↗ |
| K241358 | BLU-U® Blue Light Photodynamic Therapy Illuminator, Model 4170E | Sun Pharmaceutical Industries, Inc. | 2024-06-13 | Special | PDF ↗ |
| K233007 | Picosecond Nd:YAG Laser System; PICO LEGEND | Ami, Inc. | 2024-06-12 | Traditional | PDF ↗ |
| K240644 | Medical Diode Laser (S1Pro) | Wuhan Pioon Technology Co., Ltd. | 2024-06-10 | Traditional | PDF ↗ |
| K240222 | Dermalux Tri-Wave MD MKII (1000021); Dermalux Compact MD (1000024) | Aesthetic Technology, Ltd. | 2024-06-04 | Traditional | PDF ↗ |
| K240159 | InnoVoyce VYLO | Innovoyce | 2024-05-29 | Traditional | PDF ↗ |
| K233344 | Regenalase Laser System | Ipg Medical | 2024-05-28 | Traditional | PDF ↗ |
| K240874 | Luna Diode Laser System (TL-S20S-TWC, TL-S20S-755A , TL-S20S-810B) | Theralaser Medtech (China) Co., Ltd. | 2024-05-28 | Traditional | PDF ↗ |
| K240520 | Diode Laser Hair Removal System (SH-VD910) | Beijing Sea Heart International Science and Technologyco.Ltd | 2024-05-20 | Traditional | PDF ↗ |
| K240474 | Multi-function Platform Systems (BL-M10) | Shanghai Bele Medical Technology Co.,Ltd | 2024-05-20 | Traditional | PDF ↗ |
| K240386 | Picosecond Nd:YAG Laser Systems (BL-C10) | Shanghai Bele Medical Technology Co.,Ltd | 2024-05-16 | Traditional | PDF ↗ |
| K240752 | DEKA TORO | El.En S.P.A. | 2024-05-16 | Traditional | PDF ↗ |
| K233803 | UltraClear Laser System (N/A) | Acclaro Corporation | 2024-05-08 | Traditional | PDF ↗ |
| K233157 | VaporMAX LDD; MOJo LDD; MegaJOULE LDD | Innovaquartz, LLC | 2024-05-03 | Traditional | PDF ↗ |
| K232858 | ORskin Blue | Megabay S.A. | 2024-05-01 | Traditional | PDF ↗ |
| K240118 | Picosecond Nd:YAG Laser System | Smedtrum Medical Technology Co., Ltd. | 2024-04-30 | Traditional | PDF ↗ |
| K240816 | MeDioStar | Asclepion Laser Technologies GmbH | 2024-04-23 | Special | PDF ↗ |
| K232133 | Co2 Laser System, Models: PureLase And VanLase | Cpmt Laser (Canadian Pioneer Medical Technology Corporation) | 2024-04-16 | Traditional | PDF ↗ |
| K233757 | TitanPico Laser Workstation (PICO-450) | Rhein Laser Technologies Co., Ltd. | 2024-04-11 | Traditional | PDF ↗ |
| K234057 | NIRVANA | El.En S.P.A. | 2024-04-10 | Traditional | PDF ↗ |
| K234085 | LUNE PureHygiene | Enamel Pure | 2024-03-25 | Traditional | PDF ↗ |
| K232568 | IPG Medical Family of Thulium Fiber Lasers, Surgical Fibers, and Accessories | Ipg Medical Corporation | 2024-03-21 | Traditional | PDF ↗ |
| K240179 | Medical Diode Laser (Model: L2) | Wuhan Pioon Technology Co., Ltd. | 2024-03-21 | Traditional | PDF ↗ |
| K240537 | SMARTXIDE PRO | El.En S.P.A. | 2024-03-20 | Special | PDF ↗ |
Product code GEX · Class II · General, Plastic Surgery. Data: openFDA.