Identifiers
- 510(k) Number
- K120820 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 Giraffe Blue Spot PT Lite is a neonatal phototherapy unit designed to provide light therapy for the treatment of hyperbilirubinemia, also known as neonatal jaundice. It is intended for use during the newborn period to support the well-being of both full-term and pre-term infants.
This device is intended for use in a hospital setting and must be administered by trained professional medical staff on the order of a licensed medical practitioner. The device has received FDA 510(k) clearance.
Frequently asked questions
What is the primary clinical use of the Giraffe Blue Spot PT Lite?
This device is designed to provide light therapy for the treatment of hyperbilirubinemia, commonly referred to as neonatal jaundice. It is intended to support the well-being of both full-term and pre-term infants during the newborn period.
Who is authorized to operate this phototherapy unit?
The device is intended for use exclusively in a hospital setting. It must be administered by trained professional medical staff acting under the specific order of a licensed medical practitioner to ensure safe and appropriate treatment.
What is the regulatory status of this device?
The Giraffe Blue Spot PT Lite has received FDA 510(k) clearance. This indicates that the device has been reviewed and found to be substantially equivalent to other legally marketed devices within the same product category.
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: Giraffe Blue Spot PT Lite phototherapy system - GE Healthcare, GIRAFFE BLUE SPOT PT LITE (K120820) — FDA 510(k) | Innolitics, PDF Giraffe Blue Spot PT Lite - usme.com, K120820 FDA 510(k) - GIRAFFE BLUE SPOT PT LITE | Lumitex, Inc.
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K120820 | Class II | Active |
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Manufacturer
- Manufacturer
- Lumitex, Inc.
Sources (1)
- FDA 510(k) K120820 24 fields · synced Sep 27, 2026