# K040103: Soundskin Phototherapy System

- Pathway: 510(k) (Traditional)
- Applicant: Bhc International, Ltd.
- Decided: Jan 18, 2005 after 364 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: 1 generation back to K013623 (2002). 1 ancestor in all.
403 later devices descend from it; 1 cites it directly.
0 of 405 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K013623: Clearlight Phototheraphy System, Model CL 420, Curelight, Ltd. (2002) Summary page 1.

## Most influential descendants
- K042630: Revlight Skin Care System (2005), 402 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
- K070388: Profile Multi-Platform System (2007), 129 descendants of its own
- K060792: Illumimed (2006), 115 descendants of its own

## Indications for use
The Soundskin Phototherapy System is generally indicated to treat dermatological conditions, specifically indicated to treat moderate inflammatory Acne Vulgaris.

Source page: https://510kreport.com/device/K040103
Methodology: https://510kreport.com/methodology