Biorenew Labs, LLC
United StatesFDA applicant, unverified
- Devices
- 2
What Biorenew Labs, LLC makes
Biorenew Labs, LLC manufactures light therapy devices, including the SONILASE system for medical applications. The portfolio includes the SONILASE LIGHT THERAPY DEVICE and variants such as SONILASE BLUE, SONILASE BLUE-CLEAN, and SONILASE BLUE-UV CLEAN PLUS, designed for specific procedural uses.
These devices are classified as Class II under FDA regulations and are supported by 510(k) clearance records. The company is based in the United States.
Catalogue
Sonilase Light Therapy Device Ref K132613
Regimes: 510(k) Registry: 510(k)- Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Biorenew Labs, LLC have in the registry?
The registry currently lists 2 devices for Biorenew Labs, LLC. Devices recorded under merged duplicate company entries are counted once.
Which registries list Biorenew Labs, LLC's devices?
Among its 2 most recently registered devices, Biorenew Labs, LLC has devices listed in FDA 510(k) (2 devices).
What risk classes do Biorenew Labs, LLC's devices fall under?
Among its 2 most recently registered devices, the classes recorded for Biorenew Labs, LLC's devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Biorenew Labs, LLC in the registry?
The most recently registered devices listed for Biorenew Labs, LLC include SONILASE LIGHT THERAPY DEVICE and SONILASE BLUE, SONILASE BLUE-CLEAN, SONILASE BLUE-UV CLEAN PLUS.