Skylife

FDA 510(k) K170585 · Neolight, LLC

Substantially Equivalent

510(k) numberK170585

Submission

Device name
Skylife
Applicant
Neolight, LLC
Scottsdale, AZ, US
Received
February 28, 2017
Decision date
October 27, 2017
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
LBI – Unit, Neonatal Phototherapy
Device class
Class II (moderate risk)
Regulation
21 CFR 880.5700
Specialty
General Hospital

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K172656BiliLuxLBI · Traditional Draeger Medical Systems, Inc.05/01/2018SE
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Questions and answers

When was Skylife cleared by the FDA?

Skylife (K170585) received a 510(k) decision of Substantially Equivalent on October 27, 2017, 241 days after the submission was received.

What is the product code of K170585?

The FDA product code is LBI – Unit, Neonatal Phototherapy, a Class II (moderate risk) device regulated under 21 CFR 880.5700.