# K033181: SPR System

- Pathway: 510(k) (Traditional)
- Applicant: Radiancy (Israel), Ltd.
- Decided: Oct 24, 2003 after 23 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.
11 later devices descend from it; 2 cite it directly.
0 of 13 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 2.

## Most influential descendants
- K041554: Aip Intense Pulsed Light System (2005), 9 descendants of its own
- K062048: Aesthera Photopneumatic (PPX) System (2006), 4 descendants of its own
- K083730: Isolaz (2009), 3 descendants of its own
- K062589: Serenity PSF (Pneumatic Skin Flattening) System (2006), 3 descendants of its own
- K101415: Theraclear (2010), 1 descendant of its own

## Indications for use
The SPR is a pulsed light device intended for providing light therapy to the body and specifically indicated for treatment of pigmented and vascular lesions.

Source page: https://510kreport.com/device/K033181
Methodology: https://510kreport.com/methodology