GEX
NeuroBlate System
- Advisory panel
- General, Plastic Surgery
- Total cleared
- 2,853
Adverse events under product code GEX
product code GEX- Death
- 33
- Injury
- 3,045
- Malfunction
- 12,903
- Other
- 25
- Total
- 16,006
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recent clearances under product code GEX
1–100 of 2,853- K260017 — Picosecond Nd:YAG Laser Systems (Model: HS-298)
- K260375 — Nd: YAG Laser Therapy Systems
- K260257 — CO2 Laser System
- K252971 — Elyra Thulium Fiber Laser System and Elyra Plus Thulium Fiber Laser System (Laser, Fibers, and Accessories)
- K260632 — LASER THERMAL THERAPY KIT
- K254197 — Picasso Pro Diode Laser (002-00460)
- K253951 — Holmium Laser Therapeutic Apparatus (HZ-A); Holmium Laser Therapeutic Apparatus (HZ-B); Holmium Laser Therapeutic Apparatus (HZ-E)
- K253920 — CO2 Laser Treatment Machine (CFR3M1)
- K253828 — Medical Alexandrite and Nd:YAG laser Therapy System (CM11LP)
- K253829 — Medical Ultra-Pico Laser Treatment System (CM-SP-1064&532)
- K254271 — CAPRI
- K252599 — Diode Laser Therapy Systems (WLA-02)
- K252561 — BTL-754FF
- K252048 — 808nm semiconductor laser hair removal machine
- K251981 — Boston PICO (Boston PICO)
- K252753 — Vydence Family of Lasers
- K253633 — Holmium Laser Therapeutic Apparatus (HZ-40)
- K252369 — Boston Pico755
- K253342 — PICO-K
- K250998 — CO2 Laser Therapy System (Model: LFS-D9U)
- K251077 — JOULE 1064nm System and Accessories
- K252877 — SANDRO Dual
- K252745 — Halo Sterile Single-use Radial Fiber (Halo-R-0.40-2.5/Halo-R-0.60-2.5/Novo-R-0.60-1.8/Novo-R-0.40-1.8)
- K252658 — Medical Diode Laser Systems (TR-B)
- K253219 — LeafPure-Echo (LM-LPNdA)
- K253344 — BELLUS-Q
- K252771 — Holmium Laser System (Potent HP90); Holmium Laser System (Potent HP100); Holmium Laser System (Potent HP9120); Holmium Laser System (Potent HP140); Holmium Laser System (Potent HP150)
- K252787 — Thulium Fiber Laser System (TFL-A); Thulium Fiber Laser System (TFL-B)
- K253007 — Laser Fiber (PT-OF-A-S); Laser Fiber (PT-OF-B-S); Laser Fiber (PT-OF-C-S); Laser Fiber (PT-OF-D-S); Laser Fiber (PT-OF-E-S); Laser Fiber (PT-OF-F-S)
- K253123 — CuRAS hybrid
- K252519 — CO2 Laser Therapy System (K106)
- K252564 — Medical Diode Laser Systems (VeinCure)
- K252515 — Q-Switched Nd:Yag laser (K690)
- K251303 — Tamburo Thulium Fiber Laser System
- K252427 — Diode Laser Hair Removal Machine (GLD01)
- K252529 — Moses 200 D/F/L Laser Fiber (M0068130100); Moses 365 D/F/L Laser Fiber (M0068130110); Moses 550 D/F/L Laser Fiber (M0068130120)
- K251824 — Patriot Duo
- K252345 — Picosecond Laser Device (PF131-BI)
- K252732 — 1927nm Thulium Laser System (PZ-DJG75-01, PZ-DJG75-02)
- K253100 — MultiPulse TFL
- K252319 — Q-Switched Nd: YAG Laser machine (LFS-C13U)
- K250776 — Lithoblast Single Use Holmium Laser Fibers
- K251699 — The Botticelli (Model: Athena)
- K242946 — HESTIA (L200-A)
- K251464 — TRI-BEAM PRO, TRI-BEAM (Nd:YAG Laser unit)
- K252447 — Picosecond laser device (BMPS4)
- K251919 — Thulium Laser System (Deluxlase)
- K252063 — Medical Diode Laser Systems (BERYLAS-12N); Medical Diode Laser Systems (BERYLAS-15N); Medical Diode Laser Systems (HARLAS-45JN); Medical Diode Laser Systems (HARLAS-46JN)
- K250071 — Alma FemiLift Pixel CO2 Laser System, Delivery Devices and Accessories
- K242859 — VEGA
- K251100 — IPGTFL-02
- K251457 — Diode laser therapy device (VADER)
- K251727 — GLAM LED Facial Mask (TB-2386F)
- K250261 — Heager Medical Laser Family (Sabrina/Adolf)
- K251801 — Diode laser device (BM091)
- K251432 — Olo
- K251076 — Diode Laser Hair Removal Machine (models: T60A, T60B, T60C, T60D, T60E)
- K251339 — Medical Diode Laser Hair Removal Device (PZ-606¿, PZ-BDT68-01, PZ-BDT68-02, PZ-BDT68-03, PZ-BDT68-04)
- K250504 — Leonardo Duster
- K251149 — AviClear Laser System
- K251759 — Flexiva Pulse Laser Fiber; Flexiva Pulse TracTip Laser Fiber; Flexiva Pulse ID Laser Fiber; Flexiva Pulse ID TracTip Laser Fibers
- K250165 — Pastelle
- K243701 — AuroLase® System
- K251049 — SurgiLight 1470 Diode Laser System (Model:Halo)
- K251329 — Diode laser device (RF3120-BI)
- K251632 — Optimas MAX System
- K243683 — Deka Bluebeam
- K250782 — Fractional CO2 Laser Machine
- K250936 — Q-Switched Nd:YAG Laser (SHE-LSP101-1)
- K250465 — CO2 Laser Machine (Lume)
- K240983 — Discovery Pico; Discovery Pico Plus; Discovery Pico Derm
- K250722 — Nd: YAG Laser Therapy System (QN-1)
- K250195 — MateLaser Medical Laser Therapy Systems (ML-HIL-30, ML-HIL-60)
- K251230 — The Alma Hybrid Laser System
- K250041 — Medical Picosecond ND: YAG Laser System (PZ-6)
- K251288 — Veincare
- K250431 — Medical Diode Laser Hair Removal System (MNLT-D1)
- K251094 — Alma Veil
- K242951 — Diode laser hair removal machine (QDTM-02)
- K250183 — CO2 Laser System (CO2 Laser SST-L23)
- K250206 — Diode laser system (Night Universe; Predator)
- K250809 — Stellar M22
- K243044 — Alma Harmony
- K250656 — Medical Diode Laser (Models: MZ-GK, MZ-K20, MZ-N75)
- K250018 — Medical Diode Laser Systems (THEIA808)
- K250189 — AdvaTx
- K243630 — Medical Laser System Incanto / Evoline Platinum /Evoline
- K241791 — Medical Diode Laser Systems (GBOX-6H, GBOX-10D , GBOX-12D, GBOX-15D, VELAS Pro-30B15D, VELAS II-6H, VELAS II-15D)
- K243993 — Photon Therapy Apparatus (BL-10)
- K250113 — neoLaser Laser Surgery Fibers
- K243957 — PICOALEX
- K242207 — NOABLE LASER
- K242943 — Q Switched Nd:YAG Laser machine (QNHF-01)
- K234004 — Medical diode laser systems (CHARISMA, REGAL)
- K243588 — Single Use CO2 Laser Fiber (HAF005001)
- K241527 — Pastelle Pro
- K241643 — WONTECH Surgical Optic Fibers (BA400/BA400R/BA600/BA600R)
- K243780 — HELIOS 785 Pico (1754V2)
- 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)
- K241270 — BTL-754
Data sourced from openFDA. This site is unofficial and independent of the FDA.