USA Laser Biotech, Inc.
United StatesFDA applicant, unverified
- Devices
- 6
What USA Laser Biotech, Inc. makes
Usa Laser Biotech, Inc. manufactures infrared (IR) lamp systems, including pulsed and continuous-wave models for therapeutic and wellness applications. Products include the NEXUS XPULSE series (805 nm and 980 nm), ICL and Lumix IR heat lamp systems, and the Lumix CPS series with varying wattage outputs. The Lumix Ultra series and LUMINA systems are also part of the portfolio, designed for controlled infrared exposure.
The company’s devices are classified as Class II under FDA regulations and are listed via the 510(k) pathway. These products are intended for use in the United States, where compliance with FDA requirements is mandatory. No additional international registries or classifications are specified.
Catalogue
- Regimes: 510(k) Registry: 510(k)
- Regimes: 510(k) Registry: 510(k)
Lumix Ultra 1, Lumix Ultra 2, Lumix Ultra 3 Ref K161198
Regimes: 510(k) Registry: 510(k)Lumina 1600, 3300 And 6600 Systems Ref K052814
Regimes: 510(k) Registry: 510(k)- Regimes: 510(k) Registry: 510(k)
- Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Usa Laser Biotech, Inc. have in the registry?
The registry currently lists 6 devices for Usa Laser Biotech, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Usa Laser Biotech, Inc.'s devices?
Among its 6 most recently registered devices, Usa Laser Biotech, Inc. has devices listed in FDA 510(k) (6 devices).
What risk classes do Usa Laser Biotech, Inc.'s devices fall under?
Among its 6 most recently registered devices, the classes recorded for Usa Laser Biotech, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Usa Laser Biotech, Inc. in the registry?
The most recently registered devices listed for Usa Laser Biotech, Inc. include NEXUS XPULSE 805 IR LAMP SYSTEM, NEXUS XPULSE 980 IR LAMP SYSTEM, MODEL 805, 980, IR HEAT LAMP SYSTEMS: ICL 15 HFPL SYSTEM, ICL 60 PLUS HFPL SYSTEM (MODELS 40, 100 AND 250), ICL 100 ACTIVO SCANNER SYSTE, Lumix Ultra 1, Lumix Ultra 2, Lumix Ultra 3 and LUMINA 1600, 3300 AND 6600 SYSTEMS.