Home / 510(k) Clearances / K912908

510(k) K912908

AIR-SHIELDS MICRO-LITE PHOTOTHERAPY SYSTEM by Air-Shields Vickers, Inc. — Product Code LBI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 13, 1991
Date Received
July 2, 1991
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 Air-Shields Vickers, Inc.

  • K924679 — OXYCARE(TM) OXYGEN CONTROLLER/MONITOR (February 21, 1995)
  • K924297 — DEWETTE 2 ISOLETTE INCUBATOR HUMIDIFIER (March 18, 1993)
  • K912909 — SOLAIR (TM) INFANT INCUBATOR TRANSPARENT HOOD WARM (November 5, 1991)
  • K912910 — C100 INFANT INCUBATOR SHELF/MOUNT RAIL SYSTEM (October 30, 1991)
  • K904691 — AIR-SHIELDS VICKERS TELESCAN TELECOM DISPLAY SYST (February 19, 1991)
  • K903378 — MODEL C286 ISOLETTE INFANT INCUBATOR (October 15, 1990)
  • K895782 — NEONATAL INCUBATOR (ACCESSORY) (December 7, 1989)
  • K884086 — C100 QT VARIABLE HEIGHT ADJUSTMENT INCUBATOR (November 14, 1988)

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)