(90 days)
The BLU-U® Blue Light Photodynamic Therapy Illuminator Model 4170 is intended to provide phototherapeutic light to the body. The BLU-U® is generally indicated to treat dermatological indications. The BLU-U® is specifically indicated to treat moderate inflammatory acne vulgaris.
The BLU-U® 4170 is a compact light source that delivers a uniform distribution of blue light to the body with a spectral output at a peak wavelength of 417 nm and a Full Width at Half Maximum (FWHM) of 30 nm (407 - 437 nm). The principal parts of the system include the light unit and floor stand with timer.
The provided text is a 510(k) summary for the BLU-U® Blue Light Photodynamic Therapy Illuminator Model 4170. It explicitly states that no performance data was required by the FDA for this Class II device, and therefore, no specific acceptance criteria or studies demonstrating device performance against such criteria were submitted.
The basis for clearance was substantial equivalence to a predicate device (ClearLight™ Phototherapy Device, Model CL-420), meaning the FDA determined the new device is as safe and effective as a legally marketed device without needing new clinical studies.
Therefore, the requested information regarding acceptance criteria and studies demonstrating performance against those criteria cannot be extracted from this document, as it was not part of the submission.
Here is a summary of why the requested information is not available in the provided text:
- A table of acceptance criteria and the reported device performance: Not applicable. The document states, "No performance data is required for this Class II device nor requested by the Food and Drug Administration (Office of Device Evaluation)."
- Sample size used for the test set and the data provenance: Not applicable. No test set was used for performance evaluation as no performance data was required.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No test set requiring expert ground truth was used.
- Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable. No test set requiring ground truth adjudication was used.
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This device is a light therapy device, not an AI-assisted diagnostic tool involving human readers. No such study was conducted or required.
- If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. This device is a light therapy device, not an algorithm.
- The type of ground truth used: Not applicable. No performance data requiring ground truth was generated.
- The sample size for the training set: Not applicable. This device is a light therapy device, not a machine learning model requiring a training set.
- How the ground truth for the training set was established: Not applicable. No training set was used.
§ 878.4810 Laser surgical instrument for use in general and plastic surgery and in dermatology.
(a)
Identification. (1) A carbon dioxide laser for use in general surgery and in dermatology is a laser device intended to cut, destroy, or remove tissue by light energy emitted by carbon dioxide.(2) An argon laser for use in dermatology is a laser device intended to destroy or coagulate tissue by light energy emitted by argon.
(b)
Classification. (1) Class II.(2) Class I for special laser gas mixtures used as a lasing medium for this class of lasers. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 878.9.