LogoFDA 510(k) Search
K Number
K041212
Device Name
HOUVA 3 PHOTOTHERAPY SYSTEM
Manufacturer
NATIONAL BIOLOGICAL CORP.
Date Cleared
2004-06-09

(30 days)

Product Code
FTC
Regulation Number
878.4630
Type
Special
Panel
SU
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The HOUVA 3 Phototherapy system with PhotoSense II™ Exposure Control is a therapeutic product designed for individuals who require specific Ultraviolet radiation therapy for diagnosed skin disorders.

Device Description

Not Found

AI/ML Overview

This FDA document is a 510(k) clearance letter for a phototherapy system. It confirms that the device is substantially equivalent to legally marketed predicate devices. However, it does not contain any information regarding specific acceptance criteria, performance studies, or clinical trial data.

Therefore, I cannot provide the requested information. The document focuses on regulatory approval based on substantial equivalence, not on a detailed scientific study demonstrating the device meets performance metrics.

§ 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.