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510(k) K120168

LULLABY LED PHOTTHERAPY SYSTEM by Wipro GE Healthcare Private, Ltd. — Product Code LBI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 2, 2012
Date Received
January 19, 2012
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

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

Other clearances by Wipro GE Healthcare Private, Ltd.

  • K123681 — 1.5T 4CH LARGE FLEX COIL, 1.5 4CH SMALL FLEX COIL (February 22, 2013)
  • K121625 — LULLABY TM WARMER (September 14, 2012)
  • K110556 — MINI TELEMETRY SYSTEM (July 19, 2011)
  • K102104 — GE VIVID P3 DIAGNOSTIC ULTRASOUND IMAGING SYSTEM (October 1, 2010)

Other clearances for product code LBI

  • K251308 — SnugLit(TM) Wearable Phototherapy System (SNGL-01-US) (January 15, 2026)
  • K243372 — BiliWrap (May 29, 2025)
  • K210289 — Infant Phototherapy Equipment (May 28, 2021)
  • 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)