# K051259: Versaclear Skin Therapy System, Model 100

- Pathway: 510(k) (Traditional)
- Applicant: Theralight, Inc.
- Decided: Sep 20, 2005 after 127 days
- Product code: GEX (Powered Laser Surgical Instrument)
- Device class: 2
- Regulation: 21 CFR 878.4810
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 9 generations back to K943450 (1995). 90 ancestors in all.
47 later devices descend from it; 1 cites it directly.
0 of 138 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K031805: Blu-U, Model 4170, Dusa Pharmaceuticals, Inc. (2003) Summary page 1.
- K030883: Omnilux Blue, Photo Therapeutics Limited (2003) Summary page 1.
- K030426: Omnilux Red, Photo Therapeutics Limited (2003) Summary page 1.
- K043329: Omnilux Revive and Blue, Photo Therapeutics Limited (2005) Summary page 1.
- K885025: Houva II Uva, National Biological Corp. (1989) Summary page 1.
- K041212: Houva 3 Phototherapy System, National Biological Corp. (2004) Summary page 1.
- K841795: UV 8001K, Puva 800, Puva 180/200 1000, Waldmann Lighting Co. (1984) Summary page 2.

## Most influential descendants
- 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
- K150752: GME ExSys 308 (2015), 9 descendants of its own

## Indications for use
The VersaClear Skin Therapy System is generally indicated to treat dermatological conditions. Blue light modules are indicated to treat moderate inflammatory acne vulgaris. Red light modules are indicated for use in combination with blue light modules for the treatment of moderate inflammatory acne vulgaris, and for use alone the treatment of superficial, benign vascular, and pigmented lesions. UVA light modules are indicated for individuals who require specific ultraviolet radiation therapy for diagnosed skin disorders.

Source page: https://510kreport.com/device/K051259
Methodology: https://510kreport.com/methodology