Data / Medical devices / United States / Xintec Corporation
Xintec Corporation: FDA-registered device maker in Alameda, CA, United States, 4 510(k) clearances
Xintec Corporation is registered with the FDA (registration 2938889) in Alameda, CA, United States. It lists 1 device type. The FDA files 4 510(k) clearances under its listings, the newest dated November 9, 2021. 2 recall events name it as the recalling firm. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 2938889
- Address
- 1660 South Loop Road, Alameda, CA, United States, 94502
- Owner or operator
- XINTEC CORPORATION DBA CONVERGENT LASER TECHNOLOGIES (2938889)
- Roles
- Manufacturer
- First device listed
- April 3, 2008
- Registered through
- 2027
- Brand names listed
- LiteTouch, Odyssey, OptiLite, Optica XT Thulium Fiber Laser and Accessories, ProTouch, RotaLase, Vectra
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Powered Laser Surgical Instrument | GEX | 2 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| November 9, 2021 | K211517 | Optica XT Thulium Fiber Laser and Accessories, also known as Optica XT, Optica XT Thulium Fiber Laser, Thulium Fiber Laser 1940 nm, Optica XT Thulium Fiber Laser 1940 nm, Optica XT 60 Thulium Fiber Laser 1940 nm, Optica XT Superpulse Thulium Fiber Laser 1940 nm, OptiLITE Laser Fibers and Accessories | GEX | Substantially Equivalent | Convergent Laser Technologies | accessdata.fda.gov |
| February 3, 2010 | K082230 | VECTRA PLUS LASER SYSTEM AND ACCESSORIES | GEX | Substantially Equivalent | Xintec Corporation | accessdata.fda.gov |
| December 27, 1995 | K951910 | ODYSSEY HO:YAG SURGICAL LASER SYSTEMS & ACCESSORIES | GEX | Substantially Equivalent | Xintec Corporation | accessdata.fda.gov |
| November 29, 1995 | K951760 | OPTILITE VIII LASER SURGERY ACCESSORIES | GEX | Substantially Equivalent | Xintec Corporation | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| October 29, 2017 | 83902 | Class III | Terminated | OptiLITE, Products for Laser Surgery, Model # CGH1080F, 800 micron single-use holmium fiber assembly with flat tip, Lot Number 21144, Sterilized by Sterrad Run 4149, This device is for single-use only, sterile, UDI: 0085 | It has been determined that a lot of fiber lasers were programmed incorrectly. As a result, the fibers from this lot will produce an error and will not allow the user to use the laser when it is plugged in. | accessdata.fda.gov |
| June 23, 2017 | 77653 | Class II | Terminated | OptiLITE(TM) Products for Laser Surgery, Catalog Numbers: HTM1020F, HTM1040F, HTM1060F, HTM1010F; Manufactured by CONVERGENT LASTER TECHNOLOGIES The Odyssey 30B is approved for numerous medical procedures. Generally, the | It has been determined that the reprocessing instructions may not provide sufficiently detailed information for the cleaning, disinfection and sterilization of the products listed below. The preliminary investigation indicates that validation data related to the reprocessing of these devices may not meet newly enacted standards. | accessdata.fda.gov |
Compare with other makers
Updated November 9, 2021. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.