510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K011549Substantially Equivalent

Ohmeda Medical Spot Pt Lite Phototherapy System

GE Healthcare, Laurel MD / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K011549 is the FDA 510(k) clearance record for OHMEDA MEDICAL SPOT PT LITE PHOTOTHERAPY SYSTEM, a class II device, cleared for Ohmeda Medical on under FDA product code LBI (Unit, Neonatal Phototherapy). FDA records list 888 510(k) clearances for GE HEALTHCARE, from to . As of , FDA records show one recall naming K011549.

Clearance record

Decision date
Received
(62 days to decision)
Product code
LBI Unit, Neonatal Phototherapy
Regulation
21 CFR 880.5700
Device class
Class II
Review panel
General Hospital
Applicant
Ohmeda Medical 8880 Gorman Rd., Laurel MD
510(k) summary
Summary
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