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 |
|---|---|---|---|
| Apr 10, 2024 | K234057 | NIRVANA El.En S.P.A., IT | GEX |
| Mar 25, 2024 | K234085 | LUNE PureHygiene Enamel Pure | GEX |
| Mar 21, 2024 | K240179 | Medical Diode Laser (Model: L2) Wuhan Pioon Technology Co., Ltd., CN | GEX |
| Mar 21, 2024 | K232568 | IPG Medical Family of Thulium Fiber Lasers, Surgical Fibers, and Accessories Ipg Medical Corporation | GEX |
| Mar 20, 2024 | K240537 | SMARTXIDE PRO El.En S.P.A., IT | GEX |
| Mar 15, 2024 | K234104 | PICOANDY (Q-Switched Nd:YAG Laser) Wontech Co., Ltd., KR | GEX |
| Mar 12, 2024 | K240497 | Smartxide Tetra Pro El.En S.P.A., IT | GEX |
| Mar 12, 2024 | K240132 | EmoLED (v. 2-USA) Emoled, Srl, IT | GEX |
| Mar 8, 2024 | K240396 | Elite iQ PRO (M122K1) Cynosure, LLC | GEX |
| Feb 22, 2024 | K231876 | MultiPulse HoPLUS Asclepion Laser Technologies GmbH, DE | GEX |
| Feb 20, 2024 | K231896 | Diode Laser Therapy System Beijing Adss Development Co., Ltd., CN | GEX |
| Feb 14, 2024 | K231514 | Azure Daeshin Enterprise Co., Ltd., KR | GEX |
| Feb 8, 2024 | K233024 | Alma Harmony Alma Lasers, Inc. | GEX |
| Feb 6, 2024 | K233416 | Cryojet Plus (SHE-ACP001-1) Beijing Sano Laser S&T Development Co.,Ltd, CN | GEX |
| Feb 2, 2024 | K233756 | Artemis Diode Laser System (RL-S20S-TWC, RL-S20S-810B, RL-S20S-755) Rhein Laser Technologies Co., Ltd., CN | GEX |
| Feb 2, 2024 | K233143 | PiXel8-Reveal Rohrer Aesthetics | GEX |
| Feb 1, 2024 | K233804 | Resonic Rapid Acoustic Pulse Device Zeltiq Aesthetics, Inc. | GEX |
| Jan 30, 2024 | K231910 | DermRays Revive Wuhan Lotuxs Technology Co., Ltd., CN | GEX |
| Jan 27, 2024 | K233224 | Epilaser Pro Epilady 2000, LLC, IL | GEX |
| Jan 18, 2024 | K233077 | FlashHeal 2 (FlashHeal 2.0) Inwound Aps, DK | GEX |
| Jan 8, 2024 | K232106 | Air Gap Fiber Wontech Co., Ltd., KR | GEX |
| Jan 5, 2024 | K221766 | Solon Lmg Lasers Comercio, Importacao E Exportacao Ltda, BR | GEX |
| Dec 22, 2023 | K233304 | Omnimax S3, Omnimax S4 Sharplight Technologies, Ltd., IL | GEX |
| Dec 21, 2023 | K233018 | PICOSECOND Nd:YAG Laser System Ids, Ltd., KR | GEX |
| Dec 15, 2023 | K233237 | xeo+ Family Cutera, Inc. | GEX |
| Dec 8, 2023 | K231061 | NeuroBlate System Monteris Medical, | GEX |
| Dec 6, 2023 | K232769 | BeaMed Laser Surgery Fibers Bt Beamedical Tachnoogies Ltd. (Beamed), IL | GEX |
| Dec 1, 2023 | K233301 | ULTRApulse Alpha CO2 Laser System, Delivery Devices and Accessories Lumenis Be, Ltd., IL | GEX |
| Nov 30, 2023 | K232716 | Q-Switched Nd:Yag laser Hebei Zhemai Technology Co., Ltd., CN | GEX |
| Nov 30, 2023 | K232709 | Diode laser therapy device Hebei Zhemai Technology Co., Ltd., CN | GEX |
| Nov 28, 2023 | K232117 | Diode Laser Hair Removal (LHR-V6S-1064, LHR-V6S/B-1064) Wuhan Lotuxs Technology Co., Ltd., CN | GEX |
| Nov 2, 2023 | K232532 | Nd:Yag Laser Therapy Systems Beijing Unt Technology Co., Ltd., CN | GEX |
| Oct 27, 2023 | K233090 | DEKA AGAIN PRO family El.En S.P.A., IT | GEX |
| Oct 20, 2023 | K232236 | Echo Quanta System Spa, IT | GEX |
| Sep 28, 2023 | K231901 | Hakon, Hakon Smart Medical San Indústria DE Equipamentos Médicos Ltda., BR | GEX |
| Sep 20, 2023 | K231894 | LED Spectrum therapy instrument Shenzhenshi Sincoheren S&T Development Co., Ltd., CN | GEX |
| Sep 15, 2023 | K231791 | PENTO Nd:YAG and Alexandrite laser system Ilooda Co,., Ltd., KR | GEX |
| Sep 8, 2023 | K230535 | KARL STORZ Urological Laser Accessories Karl Storz SE & CO. KG, DE | GEX |
| Aug 25, 2023 | K223727 | Lavieen Wontech Co., Ltd., KR | GEX |
| Aug 18, 2023 | K231718 | Holmium Medical Laser Allengers Global Healthcare Private Limited, IN | GEX |
| Aug 16, 2023 | K230342 | Phototherapy System (OL-PDT950) Shanghai Omni Laser Skinology Co., Ltd., CN | GEX |
| Aug 14, 2023 | K231054 | V-Laser Wontech Co., Ltd., KR | GEX |
| Aug 10, 2023 | K230268 | ZenPro 40 BLUECORE COMPANY Co., Ltd., KR | GEX |
| Aug 3, 2023 | K231548 | Medical Diode Laser, Model S1Pro Wuhan Pioon Technology Co., Ltd., CN | GEX |
| Jul 30, 2023 | K222862 | SILKPRO Titanium Diode Laser System SILKPRO-S20S-TWC Lotuxs Medtech (Suzhou) Co., Ltd., CN | GEX |
| Jul 20, 2023 | K231945 | VenaCure EVLT NeverTouch Procedure Kits; VenaCure EVLT NeverTouch Direct Procedure Kits AngioDynamics, Inc. | GEX |
| Jul 17, 2023 | K230077 | LaserME Neauvia North America | GEX |
| Jun 6, 2023 | K230660 | AviClear Laser System Cutera, Inc. | GEX |
| Jun 6, 2023 | K212734 | Diode laser therapy device Triangel Rsd Limited, CN | GEX |
| Jun 6, 2023 | K212733 | Diode laser therapy device Beijing Star New Tech Co., Ltd., CN | GEX |
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