BiliBed Phototherapy Lamp
FDA 510(k)Class II (US FDA 510(k))
by Medela LLC
Identifiers
- 510(k) Number
- K962612 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 BiliBed Phototherapy Lamp is a neonatal phototherapy device classified as a Unit Neonatal Phototherapy system. It emits specific wavelengths of light to treat neonatal hyperbilirubinemia, a condition causing jaundice in newborns by breaking down excess bilirubin in the bloodstream. Designed for use in hospital or home settings, it provides continuous or intermittent phototherapy to safely reduce bilirubin levels in infants.
This device is intended for single-use or reusable application in general hospital settings, as indicated by its regulatory classification. Supplied as a standalone phototherapy lamp, it is not sterile and must be cleaned and maintained according to manufacturer guidelines. The BiliBed complies with FDA 510(k) clearance under the traditional review pathway, with a clearance number of K962612. It operates under regulation number 880.5700 and is categorized as a Class II medical device.
Frequently asked questions
What is the BiliBed Phototherapy Lamp used for?
The BiliBed Phototherapy Lamp is designed to treat neonatal hyperbilirubinemia, a condition causing jaundice in newborns. It emits specific wavelengths of light that break down excess bilirubin in the infant’s bloodstream, helping to safely reduce bilirubin levels. This is particularly useful in hospital or home settings where continuous or intermittent phototherapy is required.
Is the BiliBed Phototherapy Lamp sterile when supplied?
No, the BiliBed Phototherapy Lamp is not supplied sterile. It is intended for use in general hospital settings and must be cleaned and maintained according to the manufacturer’s guidelines. Sterility is not a requirement for this device, as it is classified for single-use or reusable applications.
Can the BiliBed Phototherapy Lamp be used at home?
Yes, the BiliBed Phototherapy Lamp is designed for use in both hospital and home settings. It provides continuous or intermittent phototherapy to safely reduce bilirubin levels in infants, making it suitable for environments outside of a clinical facility. However, proper cleaning and maintenance are essential to ensure safe and effective use.
What regulatory pathway does the BiliBed Phototherapy Lamp follow?
The BiliBed Phototherapy Lamp has received FDA 510(k) clearance under the traditional review pathway. It is classified as a Class II medical device and complies with regulation number 880.5700. The clearance number assigned is K962612, indicating it has been deemed substantially equivalent to a predicate device.
How is the BiliBed Phototherapy Lamp supplied?
The BiliBed Phototherapy Lamp is supplied as a standalone phototherapy lamp. It is not part of a kit or bundled with additional components. The device is intended for either single-use or reusable applications in general hospital settings, depending on facility protocols and maintenance practices.
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: MEDELA BILIBED INSTRUCTIONS FOR USE MANUAL Pdf Download, MEDELA BILIBED INSTRUCTIONS FOR USE MANUAL Pdf Download, Medela Phototherapy Lamp User Manual | AI Chat & PDF | Manualzz, Medela BiliBed Phototherapy Instructions for use | Manualzz
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K962612 | Class II | Active |
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Manufacturer
- Manufacturer
- Medela LLC
- FDA Applicant
- Medela, Inc.
Sources (1)
- FDA 510(k) K962612 24 fields · synced Oct 1, 2026