Skylife— 510(k) K170585

Substantially Equivalent

Neolight, LLC

FDA 510(k) clearance K170585 for Skylife, Substantially Equivalent on 2017-10-27. Applicant: Neolight, LLC. Device class: 2.

Clearance details

Applicant: Neolight, LLC
Product code: Code LBI
Device class: Class 2
Regulation: 21 CFR 880.5700
Advisory panel: General Hospital
Date received: 2017-02-28
Decision date: 2017-10-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Scottsdale, AZ, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code LBI

K251308 — SnugLit(TM) Wearable Phototherapy System (SNGL-01-US)2026-01-15
K243372 — BiliWrap2025-05-29
K210289 — Infant Phototherapy Equipment2021-05-28
K200031 — Neonatal Phototherapy System2020-10-05
K190899 — bili-hut2019-09-05

More clearances from Neolight, LLC

K223575 — Phoenix ICON, Phoenix ICON GO2023-09-06

Data sourced from openFDA. This site is unofficial and independent of the FDA.