Phototherapy Light
FDA 510(k) K760872 · Air-Shields, Inc.
510(k) numberK760872
Submission
- Device name
- Phototherapy Light
- Applicant
- Air-Shields, Inc.
Mchenry, IL, US - Received
- October 18, 1976
- Decision date
- November 2, 1976
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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 |
|---|---|---|
| K974248 | Watchchild Obsterical Patient Data Management SystemHGM · Traditional | 10/07/1998SE |
| K972309 | JM-102 Jaundice MeterMQM · Traditional | 09/22/1998SE |
| K971256 | Duo-Lite Phototherapy SystemLBI · Traditional | 09/24/1997SE |
| K960980 | Isolette Infant IncubatorFMZ · Traditional | 07/30/1996SE |
| K924709 | Satcare Oxygen Controller/Monitor W/ Pulse OximeteKLK · Traditional | 01/17/1996SE |
| K940951 | RW Resucitaire Infant Radiant WarmerFMT · Traditional | 05/03/1995SE |
| K940975 | C450/C400 Infant IncubatorsFMZ · Traditional | 06/23/1994SE |
| K941106 | Model TI500 Isolette Infant IncubatorFPL · Traditional | 06/10/1994SE |
| K924170 | Isolette Incubator Humidity MeterFMZ · Traditional | 02/05/1993SE |
| K922150 | Examination LampKZF · Traditional | 07/21/1992SE |
Questions and answers
When was Phototherapy Light cleared by the FDA?
Phototherapy Light (K760872) received a 510(k) decision of Substantially Equivalent on November 2, 1976, 15 days after the submission was received.
What is the product code of K760872?
The FDA product code is LBI – Unit, Neonatal Phototherapy, a Class II (moderate risk) device regulated under 21 CFR 880.5700.