# K063060: Blueshine Light Shine Systems, SP, Twin and Compact SP

- Pathway: 510(k) (Traditional)
- Applicant: Blueshine Srl
- Decided: Nov 29, 2006 after 55 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: 8 generations back to K910422 (1992). 65 ancestors in all.
No later device cites it as a predicate yet.
0 of 66 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K030897: Skinstation, Radiancy (Israel), Ltd. (2003) Summary page 1.
- K032460: Profile BBL System, Sciton, Inc (2003) Summary page 1.

## Indications for use
The Blueshine Light Shine system is Indicated for permanent hair reduction, photocoogulation of dermatological vascular lesions, photermolysis of blood vessels (treatment of facial and leg veins), and treatment of benign pigmented lesions. It Is also indicated for treatment of Inflammatory acne (acne vulgaris),

Source page: https://510kreport.com/device/K063060
Methodology: https://510kreport.com/methodology