Medical device makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under 3 spellings of its name, each linked to the record.
As of Nov 14, 2026, FDA's public records list Xintec Corporation with 27 510(k) clearances and 2 device recalls. The most recent is a device recall dated Oct 29, 2017: OptiLITE, Products for Laser Surgery, Model # CGH1080F, 800 micron single-use holmium fi….
Drug approvals, 510(k) clearances, recalls and letters, 2017 to 2026 to date
A hatched bar is a year that is not over, so its count covers only part of the year.
| Oct 29, 2017 | OptiLITE, Products for Laser Surgery, Model # CGH1080F, 800 micron single-use holmium fiber assembly with flat tip, Lot Number 21144, SterilClass III · It has been determined that a lot of fiber lasers were programmed incorrectly. As a result, the fibers from this lot wil | Device recalls |
| Jun 23, 2017 | OptiLITE(TM) Products for Laser Surgery, Catalog Numbers: HTM1020F, HTM1040F, HTM1060F, HTM1010F; Manufactured by CONVERGENT LASTER TECHNOLClass II · It has been determined that the reprocessing instructions may not provide sufficiently detailed information for the clea | Device recalls |
| Feb 3, 2010 | VECTRA PLUS LASER SYSTEM AND ACCESSORIESK082230 · GEX | 510(k) clearances |
| Apr 7, 2006 | VECTRA LASER SYSTEMK060114 · GEX | 510(k) clearances |
| Jul 30, 1999 | POLARIS DIODE LASER SYSTEM AND ACCESSORIESK990914 · GEX | 510(k) clearances |
| Jul 31, 1998 | PROTEGE II ER: YAG LASER SYSTEM AND ACCESSOIES (UPGRADE)K981627 · GEX | 510(k) clearances |
| Jul 9, 1998 | ALEXIS ALEXANDRITE LASER SYSTEM AND ACCESSORIESK981350 · GEX | 510(k) clearances |
| Nov 3, 1997 | PROTEGE ER:YAG LASER SYSTEM AND ACCESSORIESK971912 · GEX | 510(k) clearances |
| Jun 17, 1997 | DENTICA PULSED ND: YAG LASER SYSTEMS AND ACCESSORIESK971065 · GEX | 510(k) clearances |
| Mar 25, 1996 | PROTEGE ER:YAG SURGICAL LASER SYSTEM AND ACCESSORIESK951876 · GEX | 510(k) clearances |
Spellings are joined only when they reduce to the same name, or a reviewed source names the same company. Sharing an FDA establishment number (FEI) is not enough: contract sites make products for many firms. Facts marked AI were labelled by a language model from the firm's FDA names; everything else comes from FDA or Wikidata. How this page is built
