FDA Registration
Active
🇺🇸 United States
NEOLIGHT, LLC
Reg #: 3014128880
·
FEI: 3014128880
·
Expires 2026
Products
4
Proprietary Names
5
Establishment Types
4
Classifications
4
Registration Details
- Registration Name
- NEOLIGHT, LLC
- Registration Number
- 3014128880
- FEI Number
- 3014128880
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- Yes
- Address
- 1475 N Scottsdale Rd Ste 110
- City
- Scottsdale
- State
- AZ
- ZIP
- 85257
- Country
- US
Regulatory Submissions
- 510(k) Number
- K151050
Owner / Operator
- Firm Name
- NeoLight, LLC
- Operator Number
- 10056250
- Address
- 1475 N. Scottsdale Rd, Ste110
- City
- Scottsdale
- State
- AZ
- Postal Code
- 85257
- Country
- US
- Correspondent
- Erik Dawson
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Device, Biofeedback | HCC | Class 2 | Neurology | No | 2022-09-29 |
| Bassinet, Hospital | NZG | Class 2 | General Hospital | No | 2024-11-26 |
| Unit, Neonatal Phototherapy | LBI | Class 2 | General Hospital | No | 2017-11-20 |
| Pad, Neonatal Eye | FOK | Class 1 | General Hospital | No | 2020-10-11 |
Proprietary Names
PAL
Pacifier Activated Lullaby
Neolight Bassinet Basket
Skylife Phototherapy System
POSEY PHOTHERAPY EYE PROTECTOR
Establishment Types
Develop Specifications But Do Not Manufacture At This Facility
Complaint File Establishment per 21 CFR 820.198
Manufacture Medical Device
Repack or Relabel Medical Device