K120168 is an FDA 510(k) clearance for the LULLABY LED PHOTTHERAPY SYSTEM. This device is classified as a Unit, Neonatal Phototherapy (Class II - Special Controls, product code LBI).
Submitted by Wipro GE Healthcare Private, Ltd. (Laurel, US). The FDA issued a Cleared decision on May 2, 2012, 104 days after receiving the submission on January 19, 2012.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5700.
| 510(k) Number | K120168 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 19, 2012 |
| Decision Date | May 02, 2012 |
| Days to Decision | 104 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 |