Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Global USA Distribution, LLC · Predicate Candidate Screening
4 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K083272 | SKINCLEAR Q-SWITCHED ND:YAG LASER | Global USA Distribution, LLC | 2008-12-16 | 40 | 0 |
| K082028 | LASERPEEL SOFT-MET MODIFIED ERBIUM LASER | Global USA Distribution, LLC | 2008-08-08 | 22 | 0 |
| K082033 | NANNOLIGHT INTENSE PULSED LIGHT SYSTEM | Global USA Distribution, LLC | 2008-07-31 | 14 | 1 |
| K080697 | SKIN CLEAR SRVH LONG-PULSED ND: YAG LASER | Global USA Distribution, LLC | 2008-04-07 | 26 | 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