LBI — Unit, Neonatal Phototherapy Class II
FDA product code LBI covers "Unit, Neonatal Phototherapy", a Class II medical device regulated under 21 CFR 880.5700. Submissions are reviewed by the General Hospital panel. At least 20 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- LBI
- Device Class
- Class II
- Regulation Number
- 880.5700
- Submission Type
- Review Panel
- HO
- Medical Specialty
- General Hospital
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K251308 | thera b medical products | SnugLit(TM) Wearable Phototherapy System (SNGL-01-US) | January 15, 2026 |
| K243372 | gerium medical | BiliWrap | May 29, 2025 |
| K210289 | bistos co | Infant Phototherapy Equipment | May 28, 2021 |
| K200031 | avalon biomedical (shenzhen) limited | Neonatal Phototherapy System | October 5, 2020 |
| K190899 | little sparrows technologies | bili-hut | September 5, 2019 |
| K182178 | natus medical incorporated | neoBLUE blanket LED Phototherapy System | December 13, 2018 |
| K172656 | draeger medical systems | BiliLux | May 1, 2018 |
| K170585 | neolight | Skylife | October 27, 2017 |
| K163526 | neomedlight | Bilicocoon Phototherapy System | October 6, 2017 |
| K160745 | natus medical incorporated | neoBLUE compact LED Phototherapy System | December 12, 2016 |
| K160238 | international biomedical | Airborne Phototherapy Light | June 14, 2016 |
| K160305 | natus medical incorporated | neoBLUE® LED Phototherapy System | May 27, 2016 |
| K142332 | bio-med usa | BT-400 | March 20, 2015 |
| K131196 | fanem lda | INFANT PHOTOTHERAPY BILITRON SKY 5006 | February 20, 2014 |
| K120820 | lumitex | GIRAFFE BLUE SPOT PT LITE | June 8, 2012 |
| K120168 | wipro ge healthcare private | LULLABY LED PHOTTHERAPY SYSTEM | May 2, 2012 |
| K111547 | atom medical corporation | BILI-THERAPY PAD TYPE | April 12, 2012 |
| K113206 | draeger medical systems | NANOBLUTM 500 | February 17, 2012 |
| K110550 | physician engineered products | BRIGHT EMBRACE MODEL SBL60 | February 3, 2012 |
| K103735 | medix i.c | MEDILED MINI | August 15, 2011 |