Infant Phototherapy Equipment
FDA 510(k) K210289 · Bistos Co., Ltd.
510(k) numberK210289
Submission
- Device name
- Infant Phototherapy Equipment
- Applicant
- Bistos Co., Ltd.
Seongnam-Si, KR - Received
- February 2, 2021
- Decision date
- May 28, 2021
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
- Third-party review
- Yes
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 |
| 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 |
| K160238 | Airborne Phototherapy LightLBI · Abbreviated | International Biomedical | 06/14/2016SE |
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| K121267 | BT-200V Vascular DopplerHGM · Traditional | 08/02/2012SE |
| K103545 | BT-350HGM · Traditional | 05/13/2011SE |
| K100885 | Fetal Monitor Model: BT-200THGM · Traditional | 06/07/2010SE |
| K052190 | Fetal Monitor, Models BT-300 and BT-200HGM · Traditional | 10/04/2005SE |
Questions and answers
When was Infant Phototherapy Equipment cleared by the FDA?
Infant Phototherapy Equipment (K210289) received a 510(k) decision of Substantially Equivalent on May 28, 2021, 115 days after the submission was received.
What is the product code of K210289?
The FDA product code is LBI – Unit, Neonatal Phototherapy, a Class II (moderate risk) device regulated under 21 CFR 880.5700.