Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Usa Laser Biotech, Inc. · Predicate Candidate Screening
6 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
91 daysmedian FDA review time
225 days90th percentile
6clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K161198 | Lumix Ultra 1, Lumix Ultra 2, Lumix Ultra 3 | Usa Laser Biotech, Inc. | 2016-07-26 | 89 | 0 |
| K160947 | LUMIX CPS 1 IR Lamp System LUMIX CPS 2 IR Lamp System LUMIX | Usa Laser Biotech, Inc. | 2016-07-05 | 91 | 0 |
| K101893 | NEXUS BIOWAVE 7W LITE IR LAMP SYSTEM, NEXUS BIOWAVE 10W LITE | Usa Laser Biotech, Inc. | 2011-02-17 | 225 | 0 |
| K091726 | NEXUS XPULSE 805 IR LAMP SYSTEM, NEXUS XPULSE 980 IR LAMP SY | Usa Laser Biotech, Inc. | 2009-10-28 | 139 | 0 |
| K052814 | LUMINA 1600, 3300 AND 6600 SYSTEMS | Usa Laser Biotech, Inc. | 2005-11-30 | 57 | 0 |
| K042256 | IR HEAT LAMP SYSTEMS: ICL 15 HFPL SYSTEM, ICL 60 PLUS HFPL S | Usa Laser Biotech, Inc. | 2004-11-17 | 89 | 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