Cleared Traditional

K170585 - Skylife

K170585 is an FDA 510(k) clearance for Skylife, manufactured by Neolight, LLC. The device is a Class 2 General Hospital device with product code LBI cleared through the Traditional 510(k) pathway after a 241-day FDA review.

K170585 · Neolight, LLC · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2017
Decision
241d
Days
Class 2
Risk

K170585 is an FDA 510(k) clearance for the Skylife. Classified as Unit, Neonatal Phototherapy (product code LBI), Class II - Special Controls.

Submitted by Neolight, LLC (Scottsdale, US). The FDA issued a Cleared decision on October 27, 2017 after a review of 241 days - an extended review cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5700 - the FDA general hospital device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General Hospital review framework, consistent with the majority of Class II 510(k) submissions.

View all Neolight, LLC devices

FDA 510(k) Submission Details - K170585

510(k) Number K170585 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 28, 2017
Decision Date October 27, 2017
Days to Decision 241 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
112d slower than avg
Panel avg: 129d · This submission: 241d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LBI Device Classification - Class 2, Special Controls

Product Code LBI Unit, Neonatal Phototherapy
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5700
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most General Hospital devices follow this clearance model.

Regulatory Peers - LBI Unit, Neonatal Phototherapy

All 26
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