Recall Z-0692-2013— Quanta System, S.p.A.

Name: FDA recall Z-0692-2013
Creator: U.S. Food and Drug Administration
Published: 2012-11-07

Class II · Terminated

Class II FDA medical device recall by Quanta System, S.p.A., initiated 2012-11-07, terminated 2013-01-23. It names one FDA 510(k) clearance: K051113. Product: Eterna Giovinezza System, Powered Laser Surgical Instrument. Permanent hair reduction; Photocoagulation of dermatological vascular lesions; Photothermolysis of blood vessels (treatment of facial and leg veins); Treatment of benign pigmented lesions; Inflammatory acne. Reason: 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 therein were not meant to apply to the U.S. distributed devices..

Recalling firm: Quanta System, S.p.A.
Classification: Class II
Status: Terminated
Initiated: 2012-11-07
Terminated: 2013-01-23
Firm location: Solbiate Olona (VA), N/A, Italy

510(k) clearances named in this recall

1 on FDA's record

K051113 — QUANTA SYSTEM ETRNA GIOVINEZZAQuanta System Spa·cleared 2006-01-04

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

Eterna Giovinezza System, Powered Laser Surgical Instrument. Permanent hair reduction; Photocoagulation of dermatological vascular lesions; Photothermolysis of blood vessels (treatment of facial and leg veins); Treatment of benign pigmented lesions; Inflammatory acne

Reason for recall

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 therein were not meant to apply to the U.S. distributed devices.

Data sourced from openFDA. This site is unofficial and independent of the FDA.