Skylife

Unit, Neonatal Phototherapy

NeoLight, LLC

The following data is part of a premarket notification filed by Neolight, Llc with the FDA for Skylife.

Pre-market Notification Details

• Device ID: K170585
• 510k Number: K170585
• Device Name: Skylife
• Classification: Unit, Neonatal Phototherapy
• Applicant: NeoLight, LLC 1475 N Scottsdale Rd, Suite 200 Scottsdale, AZ 85257
• Contact: Sivakumar Palaniswamy
• Correspondent: Sivakumar Palaniswamy; NeoLight, LLC 1475 N Scottsdale Rd, Suite 200 Scottsdale, AZ 85257
• Product Code: LBI
• CFR Regulation Number: 880.5700 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2017-02-28
• Decision Date: 2017-10-27
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
10852788008122	K170585	000
10852788008092	K170585	000
10852788008078	K170585	000
30852788008058	K170585	000
10852788008023	K170585	000
10852788008016	K170585	000
10852788008009	K170585	000
10852788008177	K170585	000
10852788008047	K170585	000