Cleared Traditional

Luma Wrap

K142416 · Salter Labs · General Hospital

Jun 2015

Decision

288d

Days

Class 2

Risk

About This 510(k) Submission

K142416 is an FDA 510(k) clearance for the Luma Wrap, a Blanket, Neonatal Phototherapy (Class II — Special Controls, product code PDH), submitted by Salter Labs (Carlsbad, US). The FDA issued a Cleared decision on June 12, 2015, 288 days after receiving the submission on August 28, 2014. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5700.

Submission Details

510(k) Number	K142416 FDA.gov
FDA Decision	Cleared SESE
Date Received	August 28, 2014
Decision Date	June 12, 2015
Days to Decision	288 days
Submission Type	Traditional
Review Panel	General Hospital (HO)
Summary	Summary PDF

Device Classification

Product Code	PDH — Blanket, Neonatal Phototherapy
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 880.5700
Definition	Is Intended To Be Used As An Adjunct To Neonatal Phototherapy Systems Used For The Treatment Of Neonatal Hyperbilirubinemia In The Clinical Or Home Setting.