510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
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K120168Substantially Equivalent

Lullaby LED Phottherapy System

Wipro GE Healthcare Private Ltd., Laurel MD / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K120168 is the FDA 510(k) clearance record for LULLABY LED PHOTTHERAPY SYSTEM, a class II device, cleared for Wipro GE Healthcare Private, Ltd. on under FDA product code LBI (Unit, Neonatal Phototherapy). FDA records list 5 510(k) clearances for Wipro GE Healthcare Private, Ltd., from to . As of , FDA records show no recalls naming K120168.

Clearance record

Decision date
Received
(104 days to decision)
Product code
LBI Unit, Neonatal Phototherapy
Regulation
21 CFR 880.5700
Device class
Class II
Review panel
General Hospital
Applicant
Wipro GE Healthcare Private, Ltd. 8880 Gorman Rd., Laurel MD
510(k) summary
Summary PDF
Third party review
No

Clearances, product code LBI

Trailing 12 months
1 clearance under product code LBI in the twelve months to October 2026, January 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code LBI, trailing twelve months
MonthClearances
November 20250
December 20250
January 20261
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260