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510(k) K103828

BILI-THERAPY SPOT TYPE by Atom Medical Corporation — Product Code LBI

K103828 is an FDA 510(k) premarket notification submitted by Atom Medical Corporation for the device "BILI-THERAPY SPOT TYPE". The FDA issued a decision of Substantially Equivalent on March 29, 2011. The device falls under product code LBI (Unit, Neonatal Phototherapy), a Class II device regulated under 21 CFR 880.5700. Atom Medical Corporation has at least 9 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 29, 2011
Date Received
December 28, 2010
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 Atom Medical Corporation

  • K123937 — ATOM TRANSCAPSULE V-707 (May 23, 2013)
  • K120937 — SUNFLOWER WARNER (July 6, 2012)
  • K111547 — BILI-THERAPY PAD TYPE (April 12, 2012)
  • K103317 — RESUSCITATION UNIT 105 (April 20, 2011)
  • K102542 — RESUSCI FLOW; RESUSCI FLOW 104 (April 6, 2011)
  • K102227 — INFA WARMER I (January 21, 2011)
  • K102226 — DUAL INCU I (January 4, 2011)
  • K102279 — INCU I (December 29, 2010)
  • K102710 — NEO-SERVO I (December 22, 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)

FDA data resources