Data / Medical devices / United States / Neolight, LLC
Neolight, LLC: FDA-registered device maker in Scottsdale, AZ, United States, 2 510(k) clearances
Neolight, LLC is registered with the FDA (registration 3014128880) in Scottsdale, AZ, United States. It lists 4 device types. The FDA files 2 510(k) clearances under its listings, the newest dated October 27, 2017. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3014128880
- Address
- 1475 N Scottsdale Rd Ste 110, Scottsdale, AZ, United States, 85257
- Owner or operator
- NeoLight, LLC (10056250)
- Roles
- Complaint file establishment, Manufacturer, Repackager or relabeler, Specification developer
- First device listed
- November 20, 2017
- Registered through
- 2026
- Brand names listed
- Neolight Bassinet Basket, PAL, POSEY PHOTHERAPY EYE PROTECTOR, Pacifier Activated Lullaby, Skylife Phototherapy System
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Bassinet, Hospital | NZG | 2 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Device, Biofeedback | HCC | 2 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Pad, Neonatal Eye | FOK | 1 | Repackager or relabeler | accessdata.fda.gov |
| Unit, Neonatal Phototherapy | LBI | 2 | Complaint file establishment, Manufacturer, 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 |
|---|---|---|---|---|---|---|
| October 27, 2017 | K170585 | Skylife | LBI | Substantially Equivalent | Neolight, LLC | accessdata.fda.gov |
| December 22, 2015 | K151050 | Pacifier Activated Lullaby (PAL®) | HCC | Substantially Equivalent | Power Medical Devices, LLC | accessdata.fda.gov |
Compare with other makers
- All makers of Pad, Neonatal Eye
- All makers of Bassinet, Hospital
- All makers of Unit, Neonatal Phototherapy
- All makers of Device, Biofeedback
Updated October 27, 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.