Home / 510(k) Clearances / K210289

510(k) K210289

Infant Phototherapy Equipment by Bistos Co., Ltd. — Product Code LBI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 28, 2021
Date Received
February 2, 2021
Clearance Type
Traditional
Expedited Review
No
Third Party Review
Yes

Device Classification

Device Name
Unit, Neonatal Phototherapy
Device Class
Class II
Regulation Number
880.5700
Review Panel
HO
Submission Type

Other clearances by Bistos Co., Ltd.

  • K251512 — Hi bebe super (BT-150B) (September 25, 2025)
  • K232991 — BT-1000 (August 28, 2024)
  • K200675 — Hi bebe super (Models BT-150S and BT-150L) (February 10, 2021)
  • K160274 — Hi bebe plus (September 1, 2016)
  • K142799 — Model BT-220L and BT-220C (July 9, 2015)
  • K132543 — INFANT INCUBATOR (July 3, 2014)
  • K121267 — BT-200V VASCULAR DOPPLER (August 2, 2012)
  • K103545 — BT-350 (May 13, 2011)
  • K100885 — FETAL MONITOR MODEL: BT-200T (June 7, 2010)
  • K052190 — FETAL MONITOR, MODELS BT-300 AND BT-200 (October 4, 2005)

Other clearances for product code LBI

  • K251308 — SnugLit(TM) Wearable Phototherapy System (SNGL-01-US) (January 15, 2026)
  • K243372 — BiliWrap (May 29, 2025)
  • K200031 — Neonatal Phototherapy System (October 5, 2020)
  • K190899 — bili-hut (September 5, 2019)
  • K182178 — neoBLUE blanket LED Phototherapy System (December 13, 2018)
  • K172656 — BiliLux (May 1, 2018)
  • K170585 — Skylife (October 27, 2017)
  • K163526 — Bilicocoon™ Phototherapy System (October 6, 2017)
  • K160745 — neoBLUE compact LED Phototherapy System (December 12, 2016)
  • K160238 — Airborne Phototherapy Light (June 14, 2016)