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510(k) K120820

GIRAFFE BLUE SPOT PT LITE by Lumitex, Inc. — Product Code LBI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 8, 2012
Date Received
March 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 Lumitex, Inc.

  • K053568 — BILISOFT PHOTOTHERAPY SYSTEM (April 17, 2006)
  • K912747 — LULMITEX NEONATAL TRANSILLUMINATOR (December 24, 1991)

Other clearances for product code LBI

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  • 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)