Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Advanced Technology Laser Co., Ltd. · Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
34 daysmedian FDA review time
250 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K140249 | LONG PULSE ND: YAG LASER SYSTEM | Advanced Technology Laser Co., Ltd. | 2014-10-08 | 250 | 0 |
| K101555 | CO2 LASER SYSTEM | Advanced Technology Laser Co., Ltd. | 2010-09-17 | 105 | 0 |
| K102050 | Q-SWITCHED ND:YAG LASER SYSTEM, MODEL GLOBALCURE-SC6 | Advanced Technology Laser Co., Ltd. | 2010-07-29 | 8 | 0 |
| K083918 | ATL CO2 MEDICAL LASER SYSTEMS, MODELS ATL-150 AND ATL-250 | Advanced Technology Laser Co., Ltd. | 2009-02-02 | 34 | 0 |
| K083915 | ANGELITE FAMILY OF INTENSE PULSED LIGHT SYSTEMS, MODELS ANGE | Advanced Technology Laser Co., Ltd. | 2009-01-29 | 30 | 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