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The Iluminage laser device is indicated for use in the treatment of periorbital and perioral wrinkles.

Iluminage is a diode laser composed of a handpiece, base unit and a charger unit.

The provided text does not contain information about acceptance criteria or a study proving the device meets those criteria. The document is a 510(k) summary for the Iluminage Diode Laser, primarily focusing on its substantial equivalence to a predicate device for marketing approval.

Specifically, the document states:

• "Nonclinical Performance Data: none"
• "Clinical Performance Data: none"

This means that no performance studies, clinical or non-clinical, were submitted or discussed in this particular document to establish acceptance criteria or demonstrate device performance against such criteria. The approval is based on the device having the "same indications for use, the same principle of operation, the same wavelength and the same technology as the predicate devices."

Therefore, I cannot provide the requested information:

1. A table of acceptance criteria and the reported device performance.
2. Sample sized used for the test set and the data provenance.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts.
4. Adjudication method for the test set.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, and its effect size.
6. If a standalone performance study was done.
7. The type of ground truth used.
8. The sample size for the training set.
9. How the ground truth for the training set was established.

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