510(k) K243141 ยท GEX Powered Laser Surgical Instrument
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)
| Applicant | Jiangxi Medex Technology Co., Ltd., Jiangxi, CN |
| Decision | Substantially Equivalent, Dec 26, 2024 |
| Received | Sep 30, 2024 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K243141
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.