510(k) K210289
- Device
- Infant Phototherapy Equipment
- Applicant
- Bistos Co., Ltd.
- 510(k) number
- K210289
- Product code
- LBI
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2021-05-28
- Date received
- 2021-02-02
- Regulation
- 880.5700
- Classification name
- Unit, Neonatal Phototherapy
- Medical specialty
- General Hospital
- Review panel
- General Hospital
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- Yes
Applicant Contact#
- Contact
- Dae Eun Kim
- Address
- 7th Floor , A Bldg., Woolim Lions Valley 5-Cha, 302 Galmachi-Ro, Jungwon-Gu Seongnam-Si KR 13201 13201
FDA Registration Numbers#
- 3001104093
- 9611500
- 3013919653
- 3007734888
- 3006179052
- 3002807523
- 3042972073
- 3010611950
- 3014220748
- 3014128880
- 3005652389
- 3000279201
- 9617277
- 1000122810
- 9612197
- 1419937
- 2085602
- 1066270
- 2510954
- 3012348048
- 1625392
- 1000312377
- 1930027
- 9611451
- 2133810
- 3013424071
- 1000617661
- 3036470679
- 3005934741
Source Documents#
Other 510(k) Records For Product Code LBI #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K251308 | SnugLit(TM) Wearable Phototherapy System (SNGL-01-US) | Thera B Medical Products | 2026-01-15 |
| K243372 | BiliWrap | Gerium Medical, Ltd. | 2025-05-29 |
| K200031 | Neonatal Phototherapy System | Avalon Biomedical (Shenzhen) Limited | 2020-10-05 |
| K190899 | bili-hut | Little Sparrows Technologies, Inc. | 2019-09-05 |
| K182178 | neoBLUE blanket LED Phototherapy System | Natus Medical Incorporated | 2018-12-13 |
| K172656 | BiliLux | Draeger Medical Systems, Inc. | 2018-05-01 |
| K170585 | Skylife | Neolight, LLC | 2017-10-27 |
| K163526 | Bilicocoon™ Phototherapy System | Neomedlight | 2017-10-06 |
| K160745 | neoBLUE compact LED Phototherapy System | Natus Medical Incorporated | 2016-12-12 |
| K160238 | Airborne Phototherapy Light | International Biomedical | 2016-06-14 |
| K160305 | neoBLUE® LED Phototherapy System | Natus Medical Incorporated | 2016-05-27 |
| K142332 | BT-400 | Bio-Med USA | 2015-03-20 |
| K131196 | INFANT PHOTOTHERAPY BILITRON SKY 5006 | Fanem Lda | 2014-02-20 |
| K120820 | GIRAFFE BLUE SPOT PT LITE | Lumitex, Inc. | 2012-06-08 |
| K120168 | LULLABY LED PHOTTHERAPY SYSTEM | Wipro GE Healthcare Private, Ltd. | 2012-05-02 |
Legacy Summary#
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FDA Review#
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