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Sign in to claim this brandNEOLIGHT LLC
US
Last updated May 30, 2026
What NEOLIGHT LLC makes
NeoLight LLC manufactures ophthalmic imaging equipment, including fundus cameras designed for retinal examination, as well as neonatal care devices such as phototherapy units for treating jaundice in infants. Their portfolio also includes protective eye pads, neonatal beds, and specialized accessories like gel mats and light modules for infant treatment and monitoring.
The company’s devices are regulated under FDA classifications, with most falling into Class I or Class II, and are listed under the 510(k) and UDI programs. NeoLight LLC operates from the United States, adhering to U.S. medical device compliance requirements.
Written from this company's registered devices by an AI model, and not verified by a human reviewer.
Frequently asked questions
What types of medical devices does NeoLight LLC manufacture?
NeoLight LLC specializes in ophthalmic and neonatal care devices. Their portfolio includes ophthalmic fundus cameras for retinal imaging, blanket/pad infant phototherapy units to treat jaundice, protective eye pads like the Posey Eye Protection, and neonatal beds such as the NeoLight Bassinet Basket Loaner. They also produce accessories like gel mats and light modules designed for infant treatment and monitoring.
Where is NeoLight LLC based, and how does this affect its devices?
NeoLight LLC is based in the United States, which means its devices are subject to U.S. regulatory requirements, including FDA oversight. The company’s products are designed and manufactured in compliance with U.S. medical device regulations, ensuring they meet the necessary safety and performance standards for the American market.
Which regulatory registries or programs list NeoLight LLC’s devices?
NeoLight LLC’s devices are listed under the FDA’s 510(k) premarket notification program and the Unique Device Identification (UDI) system. These registries help track and regulate medical devices to ensure compliance with U.S. safety and performance requirements before they enter the market.
How are NeoLight LLC’s devices classified under FDA regulations?
NeoLight LLC’s devices are primarily classified as Class I or Class II under FDA regulations. Class I devices generally pose minimal risk and are subject to general controls, while Class II devices require additional controls due to moderate risk. The classification depends on factors like the device’s intended use and potential health impact, as outlined in FDA guidelines.
Why do some of NeoLight LLC’s devices appear repeatedly in the example list?
The repeated appearance of generic names like *Neolight* in the example list reflects the company’s broad portfolio of similar or modular devices under a shared brand. For instance, *Neolight* may refer to different models of phototherapy units, neonatal beds, or accessories, each serving distinct functions within neonatal or ophthalmic care. The exact device variations are determined by their specific design and regulatory classification.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
- —
- Website
- theneolight.com
- —
- —
- [email protected]
- Phone
- 1-866-934-8945
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- —
- DUNS Number
- 074301687
Catalogue (27)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| NeoLight Bassinet Basket Loaner | 300064 | FDA UDI | Class II | Active |
| Neolight | PCI 40-1004 | FDA UDI | Class II | Active |
| Neolight | PCI 40-1100FA | FDA UDI | Class II | Active |
| Neolight | PCI 40-1002 | FDA UDI | Class II | Active |
| GelMat | NL-SK-2-212 | FDA UDI | Class II | Active |
| Light Module | NL-SK-3 | FDA UDI | Class II | Active |
| Posey Eye Protection | NL-EP-01S-PREMIE | FDA UDI | Class I | Active |
| Neolight | PCI 40-1005 | FDA UDI | Class II | Active |
| CloudCover | NL-SK-5S | FDA UDI | Class II | Active |
| Neolight | PCI 40-2100FA | FDA UDI | Class II | Active |
| Neolight | PCI 40-1017 | FDA UDI | Class II | Active |
| Neolight | PCI 30-1000 | FDA UDI | Class II | Active |
| Neolight | PCI 40-1100 | FDA UDI | Class II | Active |
| Neolight | PCI 40-1003 | FDA UDI | Class II | Active |
| Cloud Swaddle | NL-SK-5 | FDA UDI | Class II | Unknown |
| Neolight | PCI 40-2100 | FDA UDI | Class II | Active |
| Posey Eye Protection | NL-EP-01S-NEWBORN | FDA UDI | Class I | Active |
| Skylife Controller | NL-SK-1 | FDA UDI | Class II | Active |
| GelMat Consumable | NL-SK-2-212 | FDA UDI | Class II | Active |
| NeoLight Bassinet Basket | 300063 | FDA UDI | Class II | Active |
| Skylife Lightbed | NL-SK-2 | FDA UDI | Class II | Active |
| Neolight | PCI 40-1030 | FDA UDI | Class II | Active |
| Skylife System | NL-SK | FDA UDI | Class II | Active |
| CloudCover Plus | NL-SK-8S | FDA UDI | Class II | Active |
| Posey Eye Protection | NL-EP-01S-MICRO | FDA UDI | Class I | Active |
| Phoenix ICON, Phoenix ICON GO | K223575 | FDA 510(k) | Class II | Active |
| Skylife | K170585 | FDA 510(k) | Class II | Active |
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