Centura Phototherapy Spotlight
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K010495 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 Centura Phototherapy Spotlight is a unit for neonatal phototherapy. It is classified as a Class II medical device under regulation number 880.5700.
The device received FDA 510(k) clearance K010495 on March 9, 2001, and is substantially equivalent to a predicate device. It is intended for use in a general hospital setting.
Frequently asked questions
What is the Centura Phototherapy Spotlight used for?
The Centura Phototherapy Spotlight is a unit designed for neonatal phototherapy, intended to treat jaundice in newborns by delivering light therapy in a general hospital setting.
How is the Centura Phototherapy Spotlight supplied or configured for use?
The device is supplied as a standalone unit for neonatal phototherapy, designed for placement in general hospital environments to provide targeted light treatment to infants.
Is the Centura Phototherapy Spotlight intended for single-use or repeated use?
The Centura Phototherapy Spotlight is a reusable medical device intended for repeated use in clinical settings, as it is a unit designed for ongoing neonatal phototherapy treatments.
What regulatory pathway was used for the Centura Phototherapy Spotlight?
The Centura Phototherapy Spotlight received FDA 510(k) clearance under number K010495, demonstrating substantial equivalence to a predicate device for neonatal phototherapy.
What classification does the Centura Phototherapy Spotlight hold under FDA regulations?
The Centura Phototherapy Spotlight is classified as a Class II medical device under FDA regulation number 880.5700, which governs neonatal phototherapy units.
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: CENTURA PHOTOTHERAPY SPOTLIGHT (K010495) — FDA 510 (k) | Innolitics, Home - Medical Illumination, CENTURA PHOTOTHERAPY SPOTLIGHT 510 (k) K010495 - FDA.report, Medical Illumination - CENTURA FULL VARIABLE SPOTLIGH
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K010495 | Class II | Active |
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Manufacturer
- Manufacturer
- Medical Illumination International Inc.
- FDA Applicant
- Medical Illumination International, Inc.
Sources (1)
- FDA 510(k) K010495 24 fields · synced Sep 26, 2026