RecallRadar

FDA Device recall Z-0692-2013

Eterna Giovinezza System, Powered Laser Surgical Instrument

On 2013-01-23 the FDA classified a Class II recall of Eterna Giovinezza System, Powered Laser Surgical Instrument by Quanta System S P A, citing 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….

Read the official FDA Device notice

AgencyFDA Device
Recall numberZ-0692-2013
ClassificationClass II
Statusterminated
Initiated2012-11-07
Published2013-01-23
Last updated2026-09-13 11:53 UTC
CompanyQuanta System S P A
DistributionAZ, CO, OR, TX

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.

Identifiers

code_infoAll codes and devices are applicable.

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0692-2013%22

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