K172656 is an FDA 510(k) clearance for the BiliLux. This device is classified as a Unit, Neonatal Phototherapy (Class II - Special Controls, product code LBI).
Submitted by Draeger Medical Systems, Inc. (Telford, US). The FDA issued a Cleared decision on May 1, 2018, 238 days after receiving the submission on September 5, 2017.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5700.
| 510(k) Number | K172656 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 05, 2017 |
| Decision Date | May 01, 2018 |
| Days to Decision | 238 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 |