# Neolight LLC

> Medical device manufacturer record on deviCERTS, compiled from public registries. 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.

- Canonical page: <https://devicerts.com/manufacturers/neolight-llc>
- Country: United States (FDA applicant, unverified)
- Role: Manufacturer
- DUNS: 074301687

## Figures

- Devices: 27
- FDA recalls (matched to the firm by name): 0

## Registry facts

*Every device of the manufacturer. A device listed in two registries counts in both.*

- Registries: FDA GUDID 25, FDA 510(k) 2, EUDAMED 1
- Device classes: FDA Class II 24, FDA Class I 3

## Devices

The first 27 of 27, in the order of the canonical page, which lists them all.

- [NeoLight Bassinet Basket Loaner 300064](https://devicerts.com/devices/neolight-bassinet-basket-loaner-neo-bask-lnr) · Class II · GUDID · status: Listed
- [Neolight PCI 40-1004](https://devicerts.com/devices/neolight-pci-40-1004) · Class II · GUDID · status: Active
- [Neolight PCI 40-1100FA](https://devicerts.com/devices/neolight-pci-40-1100fa) · Class II · GUDID · status: Active
- [Neolight PCI 40-1002](https://devicerts.com/devices/neolight-pci-40-1002) · Class II · GUDID · status: Active
- [GelMat NL-SK-2-212](https://devicerts.com/devices/gelmat-nl-sk-2-212) · Class II · GUDID · status: Active
- [Light Module NL-SK-3](https://devicerts.com/devices/light-module-nl-sk-3) · Class II · GUDID · status: Active
- [Posey Eye Protection NL-EP-01S-PREMIE](https://devicerts.com/devices/posey-eye-protection-nl-ep-01s-premie) · Class I · GUDID · status: Listed
- [Neolight PCI 40-1005](https://devicerts.com/devices/neolight-pci-40-1005) · Class II · GUDID · status: Active
- [CloudCover NL-SK-5S](https://devicerts.com/devices/cloudcover-nl-sk-5s) · Class II · GUDID · status: Active
- [Neolight PCI 40-2100FA](https://devicerts.com/devices/neolight-pci-40-2100fa) · Class II · GUDID · status: Active
- [Neolight PCI 40-1017](https://devicerts.com/devices/neolight-pci-40-1017) · Class II · GUDID · status: Active
- [Neolight PCI 30-1000](https://devicerts.com/devices/neolight-pci-30-1000) · Class II · EUDAMED, GUDID · status: Active
- [Neolight PCI 40-1100](https://devicerts.com/devices/neolight-pci-40-1100) · Class II · GUDID · status: Active
- [Neolight PCI 40-1003](https://devicerts.com/devices/neolight-pci-40-1003) · Class II · GUDID · status: Active
- [Cloud Swaddle NL-SK-5](https://devicerts.com/devices/cloud-swaddle-nl-sk-5) · Class II · GUDID · status: Active
- [Neolight PCI 40-2100](https://devicerts.com/devices/neolight-pci-40-2100) · Class II · GUDID · status: Active
- [Posey Eye Protection NL-EP-01S-NEWBORN](https://devicerts.com/devices/posey-eye-protection-nl-ep-01s-newborn) · Class I · GUDID · status: Listed
- [Skylife Controller NL-SK-1](https://devicerts.com/devices/skylife-controller-nl-sk-1) · Class II · GUDID · status: Active
- [GelMat Consumable NL-SK-2-212](https://devicerts.com/devices/gelmat-consumable-nl-sk-6) · Class II · GUDID · status: Active
- [NeoLight Bassinet Basket 300063](https://devicerts.com/devices/neolight-bassinet-basket-neo-bask) · Class II · GUDID · status: Listed
- [Skylife Lightbed NL-SK-2](https://devicerts.com/devices/skylife-lightbed-nl-sk-2) · Class II · GUDID · status: Active
- [Neolight PCI 40-1030](https://devicerts.com/devices/neolight-pci-40-1030) · Class II · GUDID · status: Active
- [Skylife System NL-SK](https://devicerts.com/devices/skylife-system-nl-sk) · Class II · GUDID · status: Active
- [CloudCover Plus NL-SK-8S](https://devicerts.com/devices/cloudcover-plus-nl-sk-8s) · Class II · GUDID · status: Active
- [Posey Eye Protection NL-EP-01S-MICRO](https://devicerts.com/devices/posey-eye-protection-nl-ep-01s-micro) · Class I · GUDID · status: Listed
- [Phoenix ICON, Phoenix ICON GO](https://devicerts.com/devices/phoenix-icon-phoenix-icon-go-hki) · ref K223575 · Class II · 510(k) · status: Active · decision 2023-09-06
- [Skylife](https://devicerts.com/devices/skylife-lbi) · ref K170585 · Class II · 510(k) · status: Active · decision 2017-10-27

## Source and citation

- Cite as: Neolight LLC. deviCERTS medical device catalogue. https://devicerts.com/manufacturers/neolight-llc (data as of 2026-11-15).
- Data sources: [FDA GUDID](https://accessgudid.nlm.nih.gov/), [FDA 510(k)](https://open.fda.gov/apis/device/510k/), [EUDAMED](https://ec.europa.eu/tools/eudamed)
- FDA recall data as of: 2026-11-01
- Data as of: 2026-11-15
- JSON: <https://devicerts.com/manufacturers/neolight-llc.json>
- Licence: [CC BY 4.0](https://creativecommons.org/licenses/by/4.0/). The deviCERTS layout and text are licensed under CC BY 4.0. Registry data remain under their source terms: U.S. FDA data (openFDA, AccessGUDID) are U.S. public domain; EUDAMED data are subject to the European Commission reuse terms.
- Attribution: DevicErts, https://devicerts.com/manufacturers/neolight-llc
- Compiled by deviCERTS (devicerts.com) from public medical device registries (EUDAMED, European Commission; U.S. FDA via openFDA; AccessGUDID, U.S. National Library of Medicine). deviCERTS is not an official register and gives no regulatory advice: the record in the registry itself prevails.