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Bili-Therapy Pad Type

FDA 510(k)

Class II (US FDA 510(k))

510(k) K111547

by Atom Medical Corporation

Identifiers

510(k) Number
K111547 FDA 510(k)
FDA Product Code
LBI FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 880.5700 FDA 510(k)
Regulation Number
880.5700 FDA 510(k)
Advisory Committee
General Hospital FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Bili-Therapy Pad Type is a neonatal phototherapy device designed to treat indirect hyperbilirubinemia, commonly known as neonatal jaundice. It employs blue LED light to irradiate the back of infants, facilitating the breakdown of bilirubin in the skin for absorption and excretion.

This device is intended for use in hospital settings, specifically in bassinets near a mother’s bed, and may be combined with the Bili-Therapy Spot Type for dual phototherapy treatment. Supplied as a reusable medical device, it adheres to FDA 510(k) clearance under the classification of Class II (LBI product code). Sterility and MRI safety are not specified, and proper storage and handling per manufacturer guidelines are required.

Frequently asked questions

What is the primary clinical purpose of the Bili-Therapy Pad Type and where is it typically used?

The Bili-Therapy Pad Type is designed to treat neonatal jaundice (indirect hyperbilirubinemia) by using blue LED light to break down bilirubin in an infant’s skin, aiding its absorption and excretion. It is specifically intended for use in hospital bassinets, often placed near a mother’s bed, and can be combined with the Bili-Therapy Spot Type for dual phototherapy treatment.

Is the Bili-Therapy Pad Type a single-use or reusable device, and what storage guidelines should be followed?

The Bili-Therapy Pad Type is a reusable medical device. Since sterility is not specified, proper storage and handling must follow the manufacturer’s guidelines to ensure safe, repeated use in clinical settings.

What regulatory pathway was followed for FDA clearance of this device, and what classification does it hold?

The Bili-Therapy Pad Type received FDA clearance through a 510(k) submission under the Traditional review pathway, classified as Class II under the LBI (Light-Based Infant) product code. The device was determined to be substantially equivalent to a predicate and is intended for use in general hospital settings.

Can this device be used in combination with another phototherapy device, and if so, which one?

Yes, the Bili-Therapy Pad Type is designed to be used in conjunction with the Bili-Therapy Spot Type, allowing for dual phototherapy treatment in neonatal care settings.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: ATOM Medical USA | Bili-Therapy Pad Type, BILI-THERAPY Pad Type | Product | ATOM MEDICAL, ATOM Medical USA | BILI-THERAPY PAD TYPE, PDF BILI-THERAPY Pad Type, BILI-THERAPY Spot Type | Product | ATOM MEDICAL

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Atom Medical Corporation

Sources (1)

  • FDA 510(k) K111547 24 fields · synced Sep 18, 2026