Lullaby LED Phottherapy System
FDA 510(k) K120168 · Wipro GE Healthcare Private, Ltd.
510(k) numberK120168
Submission
- Device name
- Lullaby LED Phottherapy System
- Applicant
- Wipro GE Healthcare Private, Ltd.
Laurel, MD, US - Received
- January 19, 2012
- Decision date
- May 2, 2012
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- LBI – Unit, Neonatal Phototherapy
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 880.5700
- Specialty
- General Hospital
Other 510(k)s with product code LBI
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K251308 | SnugLit(TM) Wearable Phototherapy System (SNGL-01-US)LBI · Traditional | Thera B Medical Products | 01/15/2026SE |
| K243372 | BiliWrapLBI · Traditional | Gerium Medical, Ltd. | 05/29/2025SE |
| K210289 | Infant Phototherapy EquipmentLBI · Traditional | Bistos Co., Ltd. | 05/28/2021SE |
| K200031 | Neonatal Phototherapy SystemLBI · Traditional | Avalon Biomedical (Shenzhen) Limited | 10/05/2020SE |
| K190899 | bili-hutLBI · Traditional | Little Sparrows Technologies, Inc. | 09/05/2019SE |
| K182178 | neoBLUE blanket LED Phototherapy SystemLBI · Traditional | Natus Medical Incorporated | 12/13/2018SE |
| K172656 | BiliLuxLBI · Traditional | Draeger Medical Systems, Inc. | 05/01/2018SE |
| K170585 | SkylifeLBI · Traditional | Neolight, LLC | 10/27/2017SE |
| K163526 | Bilicocoon Phototherapy SystemLBI · Traditional | Neomedlight | 10/06/2017SE |
| K160745 | neoBLUE compact LED Phototherapy SystemLBI · Traditional | Natus Medical Incorporated | 12/12/2016SE |
More from Natus Medical Incorporated
| 510(k) | Device | Decision |
|---|---|---|
| K123681 | 1.5T 4CH Large Flex Coil, 1.5 4CH Small Flex CoilMOS · Traditional | 02/22/2013SE |
| K121625 | Lullaby TM WarmerFMT · Traditional | 09/14/2012SE |
| K110556 | Mini Telemetry SystemHGM · Traditional | 07/19/2011SE |
| K102104 | GE Vivid P3 Diagnostic Ultrasound Imaging SystemIYN · Special | 10/01/2010SE |
Questions and answers
When was Lullaby LED Phottherapy System cleared by the FDA?
Lullaby LED Phottherapy System (K120168) received a 510(k) decision of Substantially Equivalent on May 2, 2012, 104 days after the submission was received.
What is the product code of K120168?
The FDA product code is LBI – Unit, Neonatal Phototherapy, a Class II (moderate risk) device regulated under 21 CFR 880.5700.