Neolight LLC
United StatesFDA applicant, unverified
Neolight LLC is a medical device manufacturer, with 27 devices listed in FDA GUDID, FDA 510(k) and EUDAMED (FDA Class II and I) as of 15 Nov 2026.
- Devices
- 27
Registry facts
- Registries
- FDA GUDID 25
- FDA 510(k) 2
- EUDAMED 1
- Device classes
- FDA Class II 24
- FDA Class I 3
- Identifiers
- DUNS 074301687
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.
Catalogue
Search and filter all 27 devicesCompany details
- DUNS number
- 074301687
- Phone
- 1-866-934-8945
Frequently asked questions
How many devices does NEOLIGHT LLC have in the registry?
The registry currently lists 27 devices for NEOLIGHT LLC. Devices recorded under merged duplicate company entries are counted once.
Which registries list NEOLIGHT LLC's devices?
Among its 27 most recently registered devices, NEOLIGHT LLC has devices listed in EUDAMED (1 device), FDA 510(k) (2 devices) and FDA GUDID (25 devices). A device can be listed in more than one registry, so these counts overlap.
What risk classes do NEOLIGHT LLC's devices fall under?
Among its 27 most recently registered devices, the classes recorded for NEOLIGHT LLC's devices are Class I and Class II. Each device page shows its own class and authorisation.
What are the newest devices from NEOLIGHT LLC in the registry?
The most recently registered devices listed for NEOLIGHT LLC include NeoLight Bassinet Basket Loaner 300064, Neolight PCI 40-1004, Neolight PCI 40-1100FA and Neolight PCI 40-1002.