# K051113: Quanta System Etrna Giovinezza

- Pathway: 510(k) (Traditional)
- Applicant: Quanta System Spa
- Decided: Jan 4, 2006 after 247 days
- Product code: GEX (Powered Laser Surgical Instrument)
- Device class: 2
- Regulation: 21 CFR 878.4810
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
4 later devices descend from it; 2 cite it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Palomar Medical Products, Inc.: named in the summary without a submission number
- (no number) Cynlosure, Inc.: named in the summary without a submission number

## Most influential descendants
- K080638: CLARO (2008), 2 descendants of its own
- K090744: CLARO (2010), 1 descendant of its own
- K150282: Shaser Skin Beauty Intense Pulsed Light System Family for Acne (2015), 0 descendants of its own
- K062721: Greenton Ecolite Ipl System (2006), 0 descendants of its own

## Recalls of this device
- Nov 7, 2012 · Class II · Z-0692-2013: Quanta System S.p.A, Italy, is notifying U.S. consignees that their website contained promotional materials for products distributed in the U.S. which did not specify that some of the claims made ther

## Indications for use
The Quanta System Etema Giovinezza system is indicated for permanent hair reduction, photocoagulation of dermatological vascular lesions, photothermolysis 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) and cutaneous lesions, including warts, scars, and striae.

Source page: https://510kreport.com/device/K051113
Methodology: https://510kreport.com/methodology