PANOSOL II TRU-BLU, MODEL UBL-417

• K Number: K070934
• Device Name: PANOSOL II TRU-BLU, MODEL UBL-417
• Manufacturer: NATIONAL BIOLOGICAL CORP.
• Date Cleared: 2007-05-22 ( 49 days)
• Product Code: FTC
• Regulation Number: 878.4630
• Type: Traditional
• Panel: SU
• Reference & Predicate Devices: N/A

Intended Use

The Panosol II Tru-Blu UBL-417 is generally indicated to treat dermatological indications. The Panosol II Tru-Blu UBL-417 is specifically indicated to treat moderate inflammatory Acne Vulgaris

Device Description

Not Found

AI/ML Overview

I'm sorry, I cannot answer your request with the provided information. The text is a 510(k) clearance letter from the FDA for a phototherapy system. It confirms that the device is substantially equivalent to a predicate device and can be marketed. It does not contain any details about acceptance criteria or a study proving the device meets those criteria, as it is a regulatory document and not a clinical study report.

Therefore, I cannot provide:

1. A table of acceptance criteria and reported device performance.
2. Sample sizes, data provenance, number of experts, qualifications of experts, adjudication methods for a test set.
3. Information about MRMC comparative effectiveness studies or standalone algorithm performance.
4. Details about the type of ground truth used or the training set size and ground truth establishment.

Regulation Number and Section

§ 878.4630 Ultraviolet lamp for dermatologic disorders.

(a)
Identification. An ultraviolet lamp for dermatologic disorders is a device (including a fixture) intended to provide ultraviolet radiation of the body to photoactivate a drug in the treatment of a dermatologic disorder if the labeling of the drug intended for use with the device bears adequate directions for the device's use with that drug.(b)
Classification. Class II.