# K073317: Starlight, Model PD9012

- Pathway: 510(k) (Traditional)
- Applicant: F.P. Rubinstein Y Cia S.R.L.
- Decided: Sep 3, 2008 after 282 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 K030897 (2003). 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)
- K030897: Skinstation, Radiancy (Israel), Ltd. (2003) Summary page 1.

## Indications for use
STARLIGHT' is a light-based system intended for the removal of unwanted hair (permanent hair reduction*) and the treatment of benign cutaneous, vascular and pigmentary lesions in skin phototypes I to V of the Fitzpatrick Table. *Permanent hair reduction is defined as a long-term stable reduction in the number of hairs regrowing after a treatment regime.

Source page: https://510kreport.com/device/K073317
Methodology: https://510kreport.com/methodology