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The Omnilux Blue is generally indicated to treat dermatological conditions and specifically indicated to treat moderate inflammatory acne vulgaris.

The Omnilux Blue is a visible light source of high spectral purity. It provides uniform or "hot-spot" free illumination. The output is pre-tuned to one wavelength with a narrow spectral bandwidth. The output wavelength is 415 + 5 nm. The Omnilux Blue base unit contains the power supplies and the control unit. Attached to the base unit are three folding arms. The LED head can be attached to the end of the arms and then positioned for patient treatment. The control unit consists of an LCD and keyboard together with the control electronics. The user interface software allows the operator to access and control all device functions.

The provided text does not contain information about specific acceptance criteria or a detailed study with performance metrics for the Omnilux Blue device. Instead, it is a 510(k) summary indicating substantial equivalence to a predicate device, the Lumenis Clearlight (K013623).

Here's a breakdown of the information that is available and what is not:

1. Table of Acceptance Criteria and Reported Device Performance

Not available. The document states: "Based upon an analysis of the overall performance characteristics for the device, Photo Therapeutics Limited believes that no significant differences exist. Therefore, the Omnilux Blue raises no new issues of safety or effectiveness." This implies that the device is considered to perform similarly to the predicate, but no specific performance metrics or acceptance criteria are provided for the Omnilux Blue itself in this summary.

2. Sample Size Used for the Test Set and Data Provenance

Not applicable, as no specific test set data or study details are provided.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

Not applicable, as no specific test set data or study details are provided.

4. Adjudication Method for the Test Set

Not applicable, as no specific test set data or study details are provided.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

Not mentioned. The document does not describe any MRMC studies or a comparison of human readers with and without AI assistance.

6. Standalone Performance Study

Not mentioned. No details about a standalone algorithm performance study are provided. The document outlines the physical device and its intended use.

7. Type of Ground Truth Used

Not applicable, as no specific data or study details are provided that would require a ground truth definition.

8. Sample Size for the Training Set

Not applicable, as this is a physical medical device (LED light source) and not an AI/algorithm-based device that would typically have a training set.

9. How the Ground Truth for the Training Set Was Established

Not applicable (see point 8).

Summary of available information from the provided text:

• Device Name: Omnilux Blue
• Indication for Use: Generally indicated to treat dermatological conditions and specifically indicated to treat moderate inflammatory acne vulgaris.
• Predicate Device: Lumenis Clearlight (K013623)
• Manufacturer's Claim: Substantially equivalent to the predicate, raising no new issues of safety or effectiveness.
• FDA Determination: FDA found the device to be substantially equivalent to legally marketed predicate devices.

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