# K040062: Levia Phototherapy System

- Pathway: 510(k) (Traditional)
- Applicant: Lerner Medical Devices, Inc.
- Decided: Feb 13, 2004 after 31 days
- Product code: FTC (Light, Ultraviolet, Dermatological)
- Device class: 2
- Regulation: 21 CFR 878.4630
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K885026 (1989). 16 ancestors in all.
280 later devices descend from it; 3 cite it directly.
0 of 297 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K022165: Theralight UV120-2 Uva/Uvb Phototherapy System, Model UV120-2, Theralight, Inc. (2002) Summary page 1.
- K024020: Theralight UV120-2 Uva/Uvb Phototherapy System, Theralight, Inc. (2003) Summary page 1.
- K020591: Bclear, Lumenis (2002) Summary page 1.
- K021762: Bclear, Lumenis, Inc. (2002) Summary page 1.
- K982082: Handisol Wound Healing, National Biological Corp. (1998) Summary page 1.
- K904427: Panosol II Uvb-206, National Biological Corp. (1990) Summary page 1.

## Most influential descendants
- K051428: Vtrac Excimer Lamp System (2005), 274 descendants of its own
- K072564: Alma Lasers Harmony XL Multi-Application Platform (2008), 266 descendants of its own
- K083899: Revlite Q-Switched ND:Yag Laser System (2009), 198 descendants of its own
- K101916: Joule Multi-Platform System (2011), 111 descendants of its own
- K103118: Revlite Q-Switched ND: Yag Laser System with Nadpiece Adaptor (2010), 92 descendants of its own

## Indications for use
The Levia Phototherapy System is intended for use in UVB phototherapy for the treatment of psoriasis, vitiligo, atopic dermatitis (eczema), seborrheic dermatitis and leucoderma. The Levia Phototherapy System is intended for use on all skin types (I -VI).

Source page: https://510kreport.com/device/K040062
Methodology: https://510kreport.com/methodology