LULLABY LED PHOTTHERAPY SYSTEM— 510(k) K120168

Name: FDA 510(k) clearance K120168
Creator: U.S. Food and Drug Administration
Published: 2012-05-02

Substantially Equivalent

Wipro GE Healthcare Private, Ltd.

FDA 510(k) clearance K120168 for LULLABY LED PHOTTHERAPY SYSTEM, Substantially Equivalent on 2012-05-02. Applicant: Wipro GE Healthcare Private, Ltd.. Device class: 2.

Clearance details

Applicant: Wipro GE Healthcare Private, Ltd.
Product code: Code LBI
Device class: Class 2
Regulation: 21 CFR 880.5700
Advisory panel: General Hospital
Date received: 2012-01-19
Decision date: 2012-05-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Laurel, MD, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code LBI

view all

K251308 — SnugLit(TM) Wearable Phototherapy System (SNGL-01-US)2026-01-15
K243372 — BiliWrap2025-05-29
K210289 — Infant Phototherapy Equipment2021-05-28
K200031 — Neonatal Phototherapy System2020-10-05
K190899 — bili-hut2019-09-05

More clearances from Wipro GE Healthcare Private, Ltd.

view all

K123681 — 1.5T 4CH LARGE FLEX COIL, 1.5 4CH SMALL FLEX COIL2013-02-22
K121625 — LULLABY TM WARMER2012-09-14
K110556 — MINI TELEMETRY SYSTEM2011-07-19
K102104 — GE VIVID P3 DIAGNOSTIC ULTRASOUND IMAGING SYSTEM2010-10-01

Data sourced from openFDA. This site is unofficial and independent of the FDA.