Data / Medical devices / France / Neomedlight
Neomedlight: FDA-registered device maker in VILLEURBANNE Auvergne-Rhone-Alpes, France, 1 510(k) clearance
Neomedlight is registered with the FDA (registration 3013919653) in VILLEURBANNE Auvergne-Rhone-Alpes, France. It lists 1 device type. The FDA files 1 510(k) clearance under its listings, the newest dated October 6, 2017. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3013919653
- Address
- Parc Emmanuelle Lenne 88 Rue Frederic Fays, VILLEURBANNE Auvergne-Rhone-Alpes, France, 69100
- Owner or operator
- NEOMEDLIGHT (10054514)
- Roles
- Manufacturer
- First device listed
- October 10, 2017
- Registered through
- 2026
- Brand names listed
- BiliCocoon
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Unit, Neonatal Phototherapy | LBI | 2 | Manufacturer | 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 |
|---|---|---|---|---|---|---|
| October 6, 2017 | K163526 | Bilicocoon Phototherapy System | LBI | Substantially Equivalent | Neomedlight | accessdata.fda.gov |
Compare with other makers
Updated October 6, 2017. 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.