Data / Medical devices / United States / Laser Biotech International
Laser Biotech International: FDA-registered device maker in North Chesterfield, VA, United States, 5 510(k) clearances
Laser Biotech International is registered with the FDA (registration 3004769071) in North Chesterfield, VA, United States. It lists 1 device type. The FDA files 5 510(k) clearances under its listings, the newest dated July 26, 2016. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3004769071
- Address
- 830 Southlake Blvd Ste C, North Chesterfield, VA, United States, 23236
- Owner or operator
- Laser Biotech International (10060098)
- Roles
- Repackager or relabeler, Specification developer
- First device listed
- November 10, 2020
- Registered through
- 2026
- Brand names listed
- L2PC01, Lumix 2 - 330W, Lumix 2 - 660W, Lumix 3 Plus, Lumix CPS 1, Lumix CPS 2, Lumix CPS 3, Lumix CPS 4 and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Lamp, Infrared, Therapeutic Heating | ILY | 2 | Repackager or relabeler, Specification developer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| July 26, 2016 | K161198 | Lumix Ultra 1, Lumix Ultra 2, Lumix Ultra 3 | ILY | Substantially Equivalent | Usa Laser Biotech, Inc. | accessdata.fda.gov |
| July 5, 2016 | 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 | Substantially Equivalent | Usa Laser Biotech, Inc. | accessdata.fda.gov |
| June 2, 2014 | K132016 | LUMIX 3 PLUS AND LUMIX 3 ULTRA SYSTEM | ILY | Substantially Equivalent | Texas Applied Biomedical Services, Inc. | accessdata.fda.gov |
| November 30, 2005 | K052814 | LUMINA 1600, 3300 AND 6600 SYSTEMS | ILY | Substantially Equivalent | Usa Laser Biotech, Inc. | accessdata.fda.gov |
| November 17, 2004 | 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 | Substantially Equivalent | Usa Laser Biotech, Inc. | accessdata.fda.gov |
Compare with other makers
Updated July 26, 2016. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.