Usa Laser Biotech, Inc.: FDA filings under this applicant name
FDA lists 6 510(k) clearances under the applicant name “Usa Laser Biotech, Inc.” (first 2004, latest 2016), across 1 product code in 1 review panel. Median 510(k) review time under this name: 90 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 2 | 90 |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| ILY | Lamp, Infrared, Therapeutic Heating | 6 | 6 |
Review panels
Most recent Usa Laser Biotech, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K161198 | Lumix Ultra 1, Lumix Ultra 2, Lumix Ultra 3 | ILY | 2016-07-26 | 89 |
| K160947 | LUMIX CPS 1 IR Lamp System LUMIX CPS 2 IR Lamp System LUMIX CPS 3 IR Lamp System LUMIX CPS 4 IR Lamp System LUMIX CPS 5 IR Lamp System | ILY | 2016-07-05 | 91 |
| K101893 | NEXUS BIOWAVE 7W LITE IR LAMP SYSTEM, NEXUS BIOWAVE 10W LITE IR LAMP SYSTEM, NEXUS BIOWAVE 30W PRO IR LAMP SYSTEM, NEXUS | ILY | 2011-02-17 | 225 |
| K091726 | NEXUS XPULSE 805 IR LAMP SYSTEM, NEXUS XPULSE 980 IR LAMP SYSTEM, MODEL 805, 980 | ILY | 2009-10-28 | 139 |
| K052814 | LUMINA 1600, 3300 AND 6600 SYSTEMS | ILY | 2005-11-30 | 57 |
| K042256 | IR HEAT LAMP SYSTEMS: ICL 15 HFPL SYSTEM, ICL 60 PLUS HFPL SYSTEM (MODELS 40, 100 AND 250), ICL 100 ACTIVO SCANNER SYSTE | ILY | 2004-11-17 | 89 |
Recalls
openFDA lists no recalls under a recalling firm named Usa Laser Biotech, Inc..
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Frequently asked questions
How many FDA 510(k) clearances are listed under Usa Laser Biotech, Inc.?
FDA lists 6 510(k) clearances under the applicant name “Usa Laser Biotech, Inc.” (first 2004, latest 2016), across 1 product code in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Usa Laser Biotech, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Usa Laser Biotech, Inc. is 90 days.
Which FDA product codes appear under Usa Laser Biotech, Inc.?
The most frequent FDA product codes under this applicant name are ILY (Lamp, Infrared, Therapeutic Heating, 6).
Next steps
- See all 6 Usa Laser Biotech, Inc. clearances with predicates and recalls
- Run predicate analysis for product code ILY, Usa Laser Biotech, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.