# K091568: LH-75 Phototherapy System

- Pathway: 510(k) (Traditional)
- Applicant: Lerner Medical Devices, Inc.
- Decided: Nov 5, 2009 after 156 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: 7 generations back to K885026 (1989). 24 ancestors in all.
No later device cites it as a predicate yet.
0 of 25 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.
- K090097: LH-75T Phototherapy System, Lerner Medical Devices, Inc. (2009) Summary page 1.
- K063621: 3 Series Phototherapy Cabinet, Daavlin Co. (2007) Summary page 1.
- K050695: Flex Controlled Phototherapy Equipment, Daavlin Distributing Co. (2005) Summary page 1.

## Indications for use
The LH-75 Phototherapy System is intended for use, by or under the direction of a physician, in UVB phototherapy for the treatment of psoriasis, vitiligo, atopic dermatitis (eczema), seborrheic dermatitis and leucoderma. The LH-75 Phototherapy System is intended for use on all skin types (I -VI).

Source page: https://510kreport.com/device/K091568
Methodology: https://510kreport.com/methodology