Cleared Traditional

K120168 - LULLABY LED PHOTTHERAPY SYSTEM

K120168 is an FDA 510(k) clearance for LULLABY LED PHOTTHERAPY SYSTEM, manufactured by Wipro GE Healthcare Private, Ltd.. The device is a Class 2 General Hospital device with product code LBI cleared through the Traditional 510(k) pathway after a 104-day FDA review.

K120168 · Wipro GE Healthcare Private, Ltd. · General Hospital
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May 2012
Decision
104d
Days
Class 2
Risk

K120168 is an FDA 510(k) clearance for the LULLABY LED PHOTTHERAPY SYSTEM. Classified as Unit, Neonatal Phototherapy (product code LBI), Class II - Special Controls.

Submitted by Wipro GE Healthcare Private, Ltd. (Laurel, US). The FDA issued a Cleared decision on May 2, 2012 after a review of 104 days - within the typical 510(k) review window.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5700 - the FDA general hospital device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General Hospital review framework, consistent with the majority of Class II 510(k) submissions.

View all Wipro GE Healthcare Private, Ltd. devices

FDA 510(k) Submission Details - K120168

510(k) Number K120168 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 19, 2012
Decision Date May 02, 2012
Days to Decision 104 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
25d faster than avg
Panel avg: 129d · This submission: 104d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LBI Device Classification - Class 2, Special Controls

Product Code LBI Unit, Neonatal Phototherapy
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5700
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most General Hospital devices follow this clearance model.

Regulatory Peers - LBI Unit, Neonatal Phototherapy

All 26
Devices cleared under the same product code (LBI) and FDA review panel - the closest regulatory comparables to K120168.
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