Identifiers
- 510(k) Number
- K103828 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 Spot Type is a Neonatal Phototherapy Unit designed for the treatment of neonatal hyperbilirubinemia. It employs blue LED technology to deliver targeted phototherapy, reducing bilirubin levels in newborns with jaundice.
This device is intended for use in neonatal intensive care units (NICU) and can be mounted on an F-rail without requiring a separate stand. Supplied as a reusable medical device, it features adjustable intensity settings and a dimmable white LED examination lamp mode. The Bili-Therapy Spot Type holds an FDA 510(k) clearance under the classification of Class II (LBI product code) and complies with regulation 880.5700.
Frequently asked questions
What clinical condition is the Bili-Therapy Spot Type designed to treat, and where is it typically used?
The Bili-Therapy Spot Type is specifically designed to treat neonatal hyperbilirubinemia, commonly known as jaundice in newborns. It employs blue LED phototherapy to help reduce elevated bilirubin levels. This device is intended for use in neonatal intensive care units (NICU) to provide targeted treatment for infants with jaundice.
Is the Bili-Therapy Spot Type a single-use or reusable device, and what features does it include for flexibility?
The Bili-Therapy Spot Type is a reusable medical device, meaning it can be used multiple times after proper cleaning and maintenance. It includes adjustable intensity settings for phototherapy and a dimmable white LED examination lamp mode, providing flexibility for both treatment and clinical assessment.
How is the Bili-Therapy Spot Type mounted in a clinical setting, and does it require additional equipment?
The Bili-Therapy Spot Type is designed to be mounted directly onto an F-rail system commonly found in NICUs, eliminating the need for a separate stand. This makes it easy to integrate into existing infrastructure without additional hardware.
What regulatory pathway was followed for the FDA clearance of the Bili-Therapy Spot Type, and what classification does it hold?
The Bili-Therapy Spot Type received FDA clearance through a traditional 510(k) pathway, classified as substantially equivalent under the product code LBI. It is categorized as a Class II medical device, reflecting its intended use in neonatal phototherapy for hyperbilirubinemia treatment.
What compliance standards does the Bili-Therapy Spot Type adhere to, and how does this affect its use?
The Bili-Therapy Spot Type complies with FDA regulation 880.5700, which governs neonatal phototherapy units. This compliance ensures the device meets established safety and performance standards for use in neonatal care settings, particularly in treating jaundice in newborns.
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 Spot Type, BILI-THERAPY Spot Type | Product | ATOM MEDICAL, ATOM Medical USA | BILI-THERAPY SPOT TYPE, AM STAGING | Bili-Therapy Spot Type, ATOM Medical USA | Bili-Therapy Spot Type
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K103828 | Class II | Active |
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Manufacturer
- Manufacturer
- Atom Medical Corporation
Sources (1)
- FDA 510(k) K103828 24 fields · synced Sep 18, 2026