Infant Phototherapy Equipment— 510(k) K210289

Substantially Equivalent

Bistos Co., Ltd.

FDA 510(k) clearance K210289 for Infant Phototherapy Equipment, Substantially Equivalent on 2021-05-28. Applicant: Bistos Co., Ltd.. Device class: 2.

Clearance details

Applicant: Bistos Co., Ltd.
Product code: Code LBI
Device class: Class 2
Regulation: 21 CFR 880.5700
Advisory panel: General Hospital
Date received: 2021-02-02
Decision date: 2021-05-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Seongnam-Si, KR

Download summary PDF View on FDA.gov ↗

Recent devices under product code LBI

K251308 — SnugLit(TM) Wearable Phototherapy System (SNGL-01-US)2026-01-15
K243372 — BiliWrap2025-05-29
K200031 — Neonatal Phototherapy System2020-10-05
K190899 — bili-hut2019-09-05
K182178 — neoBLUE blanket LED Phototherapy System2018-12-13

More clearances from Bistos Co., Ltd.

K251512 — Hi bebe super (BT-150B)2025-09-25
K232991 — BT-10002024-08-28
K200675 — Hi bebe super (Models BT-150S and BT-150L)2021-02-10
K160274 — Hi bebe plus2016-09-01
K142799 — Model BT-220L and BT-220C2015-07-09

Data sourced from openFDA. This site is unofficial and independent of the FDA.