neoBLUE compact LED Phototherapy System
FDA 510(k) clearance K160745 · decided 2016-12-12
Clearance details
- K-number
- K160745
- Device name
- neoBLUE compact LED Phototherapy System
- Applicant
- Natus Medical Incorporated
- Decision
- Substantially Equivalent
- Date received
- 2016-03-18
- Decision date
- 2016-12-12
- Days to decision
- 269 days
- Clearance type
- Traditional
- Product code
- LBI
- Device class
- 2
- Regulation number
- 880.5700
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Seattle, WA, US
- Third-party review
- No
- Expedited review
- No
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| Record | Firm | Date |
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| SnugLit(TM) Wearable Phototherapy System (SNGL-01-US) (K251308) | Thera B Medical Products | 2026-01-15 |
| BiliWrap (K243372) | Gerium Medical, Ltd. | 2025-05-29 |
| Infant Phototherapy Equipment (K210289) | Bistos Co., Ltd. | 2021-05-28 |
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| bili-hut (K190899) | Little Sparrows Technologies, Inc. | 2019-09-05 |
| neoBLUE blanket LED Phototherapy System (K182178) | Natus Medical Incorporated | 2018-12-13 |
| BiliLux (K172656) | Draeger Medical Systems, Inc. | 2018-05-01 |
| Skylife (K170585) | Neolight, LLC | 2017-10-27 |
| Bilicocoon™ Phototherapy System (K163526) | Neomedlight | 2017-10-06 |
| Airborne Phototherapy Light (K160238) | International Biomedical | 2016-06-14 |
| neoBLUE® LED Phototherapy System (K160305) | Natus Medical Incorporated | 2016-05-27 |
| BT-400 (K142332) | Bio-Med USA | 2015-03-20 |
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| OLYMPIC COOL-CAP SYSTEM (P040025/S014) | Natus Medical Incorporated | 2013-12-23 |
| OLYMPIC COOL CAP (P040025/S013) | Natus Medical Incorporated | 2013-08-29 |
| OLYMPIC COOL-CAP SYSTEM (P040025/S012) | Natus Medical Incorporated | 2012-03-27 |
| OLYMPIC COOL-CAP SYSTEM (P040025/S011) | Natus Medical Incorporated | 2010-11-23 |
| OLYMPIC COOL-CAP SYSTEM (P040025/S010) | Natus Medical Incorporated | 2010-06-28 |
| OLYMPIC COOL-CAP SYSTEM (P040025/S009) | Natus Medical Incorporated | 2009-09-18 |
| OLYMPIC COOL-CAP SYSTEM (P040025/S007) | Natus Medical Incorporated | 2009-04-22 |
| OLYMPIC COOL-CAP SYSTEM (P040025/S008) | Natus Medical Incorporated | 2008-12-24 |