K170585 is an FDA 510(k) clearance for the Skylife. This device is classified as a Unit, Neonatal Phototherapy (Class II - Special Controls, product code LBI).
Submitted by Neolight, LLC (Scottsdale, US). The FDA issued a Cleared decision on October 27, 2017, 241 days after receiving the submission on February 28, 2017.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5700.
| 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 |
| Product Code | LBI - Unit, Neonatal Phototherapy |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.5700 |