LNKClass II
Laser For Gastro-urology Use
General, Plastic Surgery · 21 CFR 878.4810
MDR events186All time
Recalls0All time
Registered firms2Currently listed
510(k) clearances60All time
Recent MDR events
186 adverse event reports on file
- PUMP, INFUSION, IMPLANTED , PROGRAMMABLEAug 12, 2023InjuryCodmanMW5137316
- LASER FOR GASTRO-UROLOGY USEMay 26, 2023Malfunction17009473
- SIGNA ARTISTApr 22, 2021MalfunctionGeneral Electric Company11705943
- SIGNA ARTISTFeb 9, 2021MalfunctionGeneral Electric Company11301046
- LASER PERIPHERALMay 23, 2013MalfunctionLaser PeripheralsMW5030328
- BOSTON SCIENTIFIC DUOTOME SIDELITE 550Dec 14, 2011InjuryLumenis2497844
- DUOTOME SIDELITE 550 FIBER DELIVERY DEVICEJun 29, 2010InjuryLumenisMW5016643
- AMSJun 24, 2010InjuryAmerican Medical Systems (ams)MW5016522
- BOSTON SCIENTIFIC SIDELITE 550 LASER FIBERJun 14, 2010InjuryBoston ScientificMW5016343
- BOSTON SCIENTIFICJun 10, 2010MalfunctionBoston ScientificMW5016335
Event type breakdown
Malfunction111
Injury49
Other16
Unspecified7
Death3
Recalls
0 recall events for this product code
No recalls on file for this product code.
Registered firms
2 firms currently registered for this product code
510(k) clearances
60 clearances for this product code
- Teknomed, Inc.May 21, 1993
K925395 · TECHNOMED PULSOLITH 4000 LASER SYSTEM
- Candela Laser Corp.Jul 13, 1990
K901723 · MDL-2000 LASERTRIPTER
- Minnesota Laser Corp.Jul 12, 1988
K874255 · ND:YAG SURGICAL LASER FOR ENDO. GASTRO/URO. APPLI.
- Minnesota Laser Corp.Jul 12, 1988
K874253 · ND:YAG SURGICAL LASER FOR GASTRO/UROLOGY APPLICA.
- Sharplan Lasers, Inc.Apr 14, 1988
K880256 · MODEL 4060 N ND:YAG LASER FOR GASTROENTEROLOGY USE
- Sharplan Lasers, Inc.Apr 14, 1988
K880193 · MODEL 4060 N ND:YAG LASER FOR UROLOGICAL USE
- Surgilase, Inc.Apr 13, 1988
K875039 · ND:YAG 100 SURGICAL LASER FOR GASTRO. AND UROLOGY
- Cooper Lasersonics, Inc.Apr 11, 1988
K880171 · MODEL 4900 ND:YAG LASER FOR GASTRO & GENITOUR APPL