Xintec Corporation
Medical device manufacturer in Alameda, CA.
27510(k) clearances
0PMA approvals
2recalls
Device types
510(k) clearances
| 510(k) | Device | Decision |
|---|---|---|
| K082230 | Vectra Plus Laser System and AccessoriesGEX · Traditional | 02/03/2010SE |
| K060114 | Vectra Laser SystemGEX · Traditional | 04/07/2006SE |
| K990914 | Polaris Diode Laser System and AccessoriesGEX · Traditional | 07/30/1999SE |
| K981627 | Protege II Er: Yag Laser System and Accessoies (Upgrade)GEX · Traditional | 07/31/1998SE |
| K981350 | Alexis Alexandrite Laser System and AccessoriesGEX · Traditional | 07/09/1998SE |
| K971912 | Protege Er:Yag Laser System and AccessoriesGEX · Traditional | 11/03/1997SE |
| K971065 | Dentica Pulsed ND: Yag Laser Systems and AccessoriesGEX · Traditional | 06/17/1997SE |
| K951935 | Prodigy Superpulse Nd:Yag Surgical Laser Systems & AccessoriesGEX · Traditional | 03/25/1996SE |
| K951876 | Protege Er:Yag Surgical Laser System and AccessoriesGEX · Traditional | 03/25/1996SE |
| K951910 | Odyssey Ho:Yag Surgical Laser Systems & AccessoriesGEX · Traditional | 12/27/1995SE |
| K951760 | Optilite Viii Laser Surgery AccessoriesGEX · Traditional | 11/29/1995SE |
| K945181 | Genera 100 Surgical SystemGEX · Traditional | 01/20/1995SE |
| K944965 | Optilite Vi Fiberoptic AccessoriesGEX · Traditional | 01/06/1995SE |
| K944704 | Optilite (TM) Vii Fiberoptic Accessories Rotalase (TM) Angle Delivery Systemsn and…GEX · Traditional | 01/06/1995SE |
| K944749 | Optica 100 Superpulsed Laser SystemGEX · Traditional | 12/22/1994SE |
| K944474 | Optilite V Fiberoptic AccessoriesGEX · Traditional | 12/15/1994SE |
| K942759 | Opticon(Tm) Connector Adapter IIGEX · Traditional | 08/31/1994SE |
| K923599 | Optilite Fiberoptic Delivery SystemsGEX · Traditional | 05/17/1993SE |
| K930159 | Opticon(Tm) Connector AdapterGEX · Traditional | 04/07/1993SE |
| K924166 | Optilink(Tm) LPM (Laser Power Modulator)GEX · Traditional | 02/05/1993SE |
| K914678 | Odyssey Ho:Yag Surgical Laser SystemGEX · Traditional | 09/21/1992SE |
| K914679 | Prodigy Nd:Yag Surgical Laser SystemGEX · Traditional | 04/07/1992SE |
| K913839 | Optica 25 Nd:Yag Dental Laser SystemGEX · Traditional | 03/13/1992SE |
| K912703 | Optica 60 Nd;Yag Surgical Laser SystemGEX · Traditional | 10/11/1991SE |
| K910114 | Optilite (TM) Fiberoptic Delivery Systems and AcceGEX · Traditional | 04/09/1991SE |
| K902871 | Optilite Fiberoptic Delivery SystemsGEX · Traditional | 09/24/1990SE |
| K901710 | Optica 120 Nd:Yag Surgical Laser SystemGEX · Traditional | 09/20/1990SE |
Recalls
| Recall | Product | Initiated |
|---|---|---|
| Z-0162-2020 Class III | OptiLITE, Products for Laser Surgery, Model # CGH1080F, 800 micron single-use holmium…It has been determined that a lot of fiber lasers were programmed incorrectly. As a result, the fibers from… | 10/29/2017Terminated |
| Z-2866-2017 Class II | OptiLITE(TM) Products for Laser Surgery, Catalog Numbers: HTM1020F, HTM1040F, HTM1060F…It has been determined that the reprocessing instructions may not provide sufficiently detailed information… | 06/23/2017Terminated |