# K041212: Houva 3 Phototherapy System

- Pathway: 510(k) (Special)
- Applicant: National Biological Corp.
- Decided: Jun 9, 2004 after 30 days
- Product code: FTC (Light, Ultraviolet, Dermatological)
- Device class: 2
- Regulation: 21 CFR 878.4630
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
55 later devices descend from it; 4 cite it directly.
0 of 56 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K051259: Versaclear Skin Therapy System, Model 100 (2005), 47 descendants of its own
- K090762: LEDA (2009), 46 descendants of its own
- K200104: Oxylight (2020), 24 descendants of its own
- K240089: Face Patches (MT-12MA, MT-12MC) (2024), 16 descendants of its own
- K222751: LED Light Therapy Device, KN-7000L (2023), 11 descendants of its own

## Recalls of this device
- Feb 19, 2008 · Not classified · Z-1309-2008: Software allows operator to override "low line voltage" error warning and store light intensity value.

## Indications for use
The I IOUVA 3 Phototherapy system with PhotoSense [ITM Exposure Control is a therapeutic product designed for individuals who require specific Ultraviolet radiation therapy for diagnosed skin disorders.

Source page: https://510kreport.com/device/K041212
Methodology: https://510kreport.com/methodology