# K070870: Skin Care Light

- Pathway: 510(k) (Traditional)
- Applicant: Transverse Industries Co.
- Decided: Oct 10, 2007 after 195 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.
No later device cites it as a predicate yet.
0 of 2 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 2.

## Indications for use
Skin Care Light is intended to provide phototherapeutic light to the face. It is used to treat dermatological conditions by exposing the surface of the skin to the blue spectrum. It is specifically indicated to treat moderate inflammatory acne vulgaris.

Source page: https://510kreport.com/device/K070870
Methodology: https://510kreport.com/methodology