Panels › General, Plastic Surgery › Product code GEX · Class 2
Powered Laser Surgical Instrument
Regulation 878.4810
72510(k)s in 12 months (2,892 all time)
6recalls in 12 months (201 all time)
150recalls that name a 510(k)
Top companies in GEX
| Company | 510(k)s | Recalls |
|---|---|---|
| Cynosure, Inc. | 84 | 1 |
| Lumenis | 60 | 11 |
| Sharplan Lasers, Inc. | 66 | 0 |
| Quanta System Spa | 57 | 6 |
| Candela Corp. | 53 | 5 |
| Laserscope | 49 | 0 |
| Trimedyne, Inc. | 48 | 0 |
| Heraeus Lasersonics, Inc. | 37 | 0 |
| Surgical Laser Technologies, Inc. | 35 | 0 |
| Boston Scientific | 11 | 23 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jul 3, 2025 | K250165 | Pastelle Wontech Co., Ltd., KR | GEX |
| Jul 2, 2025 | K251049 | SurgiLight 1470 Diode Laser System (Model:Halo) Micro-Energy Medical Technology Co., Ltd., CN | GEX |
| Jul 2, 2025 | K243701 | AuroLase® System Nanospectra Biosciences, Inc. | GEX |
| Jun 27, 2025 | K251329 | Diode laser device (RF3120-BI) Risu Medical Technology Co., Ltd., CN | GEX |
| Jun 26, 2025 | K251632 | Optimas MAX System InMode , Ltd., FR | GEX |
| Jun 12, 2025 | K250936 | Q-Switched Nd:YAG Laser (SHE-LSP101-1) Beijing Sano Laser S&T Development Co.,Ltd, CN | GEX |
| Jun 12, 2025 | K250782 | Fractional CO2 Laser Machine Zhengzhou PZ Laser Slim Technology Co., Ltd., CN | GEX |
| Jun 12, 2025 | K243683 | Deka Bluebeam El.En S.P.A., IT | GEX |
| Jun 9, 2025 | K250465 | CO2 Laser Machine (Lume) Nanjing Bestview Laser S&T Co., Ltd., CN | GEX |
| Jun 6, 2025 | K250722 | Nd: YAG Laser Therapy System (QN-1) Hebei JT Medical Co., Ltd., CN | GEX |
| Jun 6, 2025 | K240983 | Discovery Pico; Discovery Pico Plus; Discovery Pico Derm Quanta System Spa, IT | GEX |
| May 30, 2025 | K250195 | MateLaser Medical Laser Therapy Systems (ML-HIL-30, ML-HIL-60) Matelaser, Inc. | GEX |
| May 21, 2025 | K251230 | The Alma Hybrid Laser System Alma Lasers, Inc. | GEX |
| May 14, 2025 | K251288 | Veincare Wontech Co., Ltd., KR | GEX |
| May 14, 2025 | K250041 | Medical Picosecond ND: YAG Laser System (PZ-6) Zhengzhou PZ Laser Slim Technology Co., Ltd., CN | GEX |
| May 12, 2025 | K250431 | Medical Diode Laser Hair Removal System (MNLT-D1) Shandong Moonlight Electronics Tech Co., Ltd., CN | GEX |
| May 6, 2025 | K251094 | Alma Veil Wontech Co., Ltd., KR | GEX |
| Apr 28, 2025 | K242951 | Diode laser hair removal machine (QDTM-02) Beijing Nubway S&T Co., Ltd., CN | GEX |
| Apr 24, 2025 | K250206 | Diode laser system (Night Universe; Predator) Ivylaser (Beijing) Technology Co.,Ltd, CN | GEX |
| Apr 24, 2025 | K250183 | CO2 Laser System (CO2 Laser SST-L23) Zhuozhou Summer Star Technologies Co., Ltd., CN | GEX |
| Apr 16, 2025 | K250809 | Stellar M22 Lumenis Be, Ltd., IL | GEX |
| Apr 11, 2025 | K243044 | Alma Harmony Alma Lasers, Inc. | GEX |
| Apr 4, 2025 | K250656 | Medical Diode Laser (Models: MZ-GK, MZ-K20, MZ-N75) Wuhan Pioon Technology Co., Ltd., CN | GEX |
| Apr 1, 2025 | K250189 | AdvaTx Advalight Aps, DK | GEX |
| Apr 1, 2025 | K250018 | Medical Diode Laser Systems (THEIA808) Gigaalaser Company , Ltd., CN | GEX |
| Mar 21, 2025 | K243630 | Medical Laser System Incanto / Evoline Platinum /Evoline Solar LS Cjsc, BY | GEX |
| Mar 19, 2025 | 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., CN | GEX |
| Mar 13, 2025 | K250113 | neoLaser Laser Surgery Fibers G.N.S Neolaser , Ltd., IL | GEX |
| Mar 13, 2025 | K243993 | Photon Therapy Apparatus (BL-10) Xemis Medical Technology (Shenzhen) Co., Ltd., CN | GEX |
| Mar 12, 2025 | K243957 | PICOALEX Wontech Co., Ltd., KR | GEX |
| Mar 7, 2025 | K242207 | NOABLE LASER Daeju Meditech Engineering Co., Ltd., KR | GEX |
| Mar 3, 2025 | K242943 | Q Switched Nd:YAG Laser machine (QNHF-01) Beijing Nubway S&T Co., Ltd., CN | GEX |
| Feb 20, 2025 | K234004 | Medical diode laser systems (CHARISMA, REGAL) Reveal Lasers , Ltd., IL | GEX |
| Feb 19, 2025 | K243588 | Single Use CO2 Laser Fiber (HAF005001) Quanta System Spa, IT | GEX |
| Feb 14, 2025 | K241643 | WONTECH Surgical Optic Fibers (BA400/BA400R/BA600/BA600R) Wontech Co., Ltd., KR | GEX |
| Feb 14, 2025 | K241527 | Pastelle Pro Wontech Co., Ltd., KR | GEX |
| Feb 7, 2025 | K243780 | HELIOS 785 Pico (1754V2) Laseroptek Co., Ltd., KR | GEX |
| Feb 6, 2025 | K243465 | Diode Laser Hair Removal Device (EVOLUTION MEDICAL); Diode Laser Hair Removal Device (M-I-X MEDICAL); Diode Laser Hair R Guangzhou Chuang Zao Mei Technology Co., Ltd., CN | GEX |
| Jan 30, 2025 | K241270 | BTL-754 BTL Industries, Inc. | GEX |
| Jan 27, 2025 | K242941 | CO2 Laser Therapy Systems (SHE-LSP003-1) Beijing Sano Laser S&T Development Co.,Ltd, CN | GEX |
| Dec 30, 2024 | K243445 | Splendor X (Alex, Alex2, Nd:YAG, Alex+Nd:YAG) Bios S.R.L., IT | GEX |
| Dec 26, 2024 | K243141 | Diode Laser System (LaserPro D 980); Diode Laser System (LaserPro D 810); Diode Laser System (Aurolance 980); Diode Lase Jiangxi Medex Technology Co., Ltd., CN | GEX |
| Dec 26, 2024 | K243037 | Diode Laser System model Dawn-S Shanghai Wonderful Opto-Electrics Tech.Co.,Ltd, CN | GEX |
| Dec 22, 2024 | 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 Jiangxi Medex Technology Co., Ltd., CN | GEX |
| Dec 21, 2024 | K243147 | LGO-Surgical Laser Fibers Light Guide Optics International , Ltd., LV | GEX |
| Dec 20, 2024 | K242534 | HandPICO Fractional Laser Handpiece Tip Vydence Medical, BR | GEX |
| Dec 20, 2024 | K241670 | Fractional CO2 Laser Therapy System (FG900-S); Fractional CO2 Laser Therapy System (FG900-S2) Beijing Adss Development Co., Ltd., CN | GEX |
| Dec 17, 2024 | K242987 | Thulium Fiber Laser (FiberLAZE+, FiberLAZE) Allengers Global Healthcare Private Limited, IN | GEX |
| Nov 19, 2024 | K242293 | Medical Thulium Fiber Laser Systems (UroFiber 60Q) Rhein Laser Technologies Co., Ltd., CN | GEX |
| Nov 18, 2024 | K241498 | Diode laser Treatment System (K18) Hebei Keylaser Sci-Tech Co.,Ltd, CN | GEX |
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