Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Xintec Corporation — Predicate Candidate Screening
26 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
134 daysmedian FDA review time
339 days90th percentile
26clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K082230 | VECTRA PLUS LASER SYSTEM AND ACCESSORIES | Xintec Corporation | 2010-02-03 | 545 | 0 |
| K990914 | POLARIS DIODE LASER SYSTEM AND ACCESSORIES | Xintec Corporation | 1999-07-30 | 134 | 0 |
| K981627 | PROTEGE II ER: YAG LASER SYSTEM AND ACCESSOIES (UPGRADE) | Xintec Corporation | 1998-07-31 | 85 | 0 |
| K981350 | ALEXIS ALEXANDRITE LASER SYSTEM AND ACCESSORIES | Xintec Corporation | 1998-07-09 | 86 | 0 |
| K971912 | PROTEGE ER:YAG LASER SYSTEM AND ACCESSORIES | Xintec Corporation | 1997-11-03 | 206 | 0 |
| K971065 | DENTICA PULSED ND: YAG LASER SYSTEMS AND ACCESSORIES | Xintec Corporation | 1997-06-17 | 85 | 0 |
| K951876 | PROTEGE ER:YAG SURGICAL LASER SYSTEM AND ACCESSORIES | Xintec Corporation | 1996-03-25 | 339 | 0 |
| K951935 | PRODIGY SUPERPULSE ND:YAG SURGICAL LASER SYSTEMS & ACCESSORI | Xintec Corporation | 1996-03-25 | 335 | 0 |
| K951910 | ODYSSEY HO:YAG SURGICAL LASER SYSTEMS & ACCESSORIES | Xintec Corporation | 1995-12-27 | 247 | 0 |
| K951760 | OPTILITE VIII LASER SURGERY ACCESSORIES | Xintec Corporation | 1995-11-29 | 226 | 0 |
| K945181 | GENERA 100 SURGICAL SYSTEM | Xintec Corporation | 1995-01-20 | 88 | 0 |
| K944704 | OPTILITE (TM) VII FIBEROPTIC ACCESSORIES ROTALASE (TM) ANGLE | Xintec Corporation | 1995-01-06 | 105 | 0 |
| K944965 | OPTILITE VI FIBEROPTIC ACCESSORIES | Xintec Corporation | 1995-01-06 | 87 | 0 |
| K944749 | OPTICA 100 SUPERPULSED LASER SYSTEM | Xintec Corporation | 1994-12-22 | 87 | 0 |
| K944474 | OPTILITE V FIBEROPTIC ACCESSORIES | Xintec Corporation | 1994-12-15 | 97 | 0 |
| K942759 | OPTICON(TM) CONNECTOR ADAPTER II | Xintec Corporation | 1994-08-31 | 79 | 0 |
| K923599 | OPTILITE FIBEROPTIC DELIVERY SYSTEMS | Xintec Corporation | 1993-05-17 | 301 | 0 |
| K930159 | OPTICON(TM) CONNECTOR ADAPTER | Xintec Corporation | 1993-04-07 | 84 | 0 |
| K924166 | OPTILINK(TM) LPM (LASER POWER MODULATOR) | Xintec Corporation | 1993-02-05 | 170 | 0 |
| K914678 | ODYSSEY HO:YAG SURGICAL LASER SYSTEM | Xintec Corporation | 1992-09-21 | 339 | 0 |
| K914679 | PRODIGY ND:YAG SURGICAL LASER SYSTEM | Xintec Corporation | 1992-04-07 | 172 | 0 |
| K913839 | OPTICA 25 ND:YAG DENTAL LASER SYSTEM | Xintec Corporation | 1992-03-13 | 200 | 0 |
| K912703 | OPTICA 60 ND;YAG SURGICAL LASER SYSTEM | Xintec Corporation | 1991-10-11 | 114 | 0 |
| K910114 | OPTILITE (TM) FIBEROPTIC DELIVERY SYSTEMS AND ACCE | Xintec Corporation | 1991-04-09 | 89 | 0 |
| K902871 | OPTILITE FIBEROPTIC DELIVERY SYSTEMS | Xintec Corporation | 1990-09-24 | 87 | 0 |
| K901710 | OPTICA 120 ND:YAG SURGICAL LASER SYSTEM | Xintec Corporation | 1990-09-20 | 160 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda