Device recall

Z-0692-2013: Eterna Giovinezza System, Powered Laser Surgical Instrument. Permanent hair…

FDA device recall · Class II · Quanta System, S.p.A.

Key facts

Recall number (Z-number) Z-0692-2013
Recall event 64039
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
Product code GEX
Recalling firm Quanta System, S.p.A.
Recall class Class II
Status Terminated
Termination date Jan 23, 2013
510(k) numbers K051113
FEI number 3004378299

At a glance

  • 1–9 Linked 510(k)s
  • 1–9 Products in the same recall event
  • 100–999 Recalled products with this product code

Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.

About FDA device recalls (products)

Each recalled device product receives a Z-number. Recall details such as root cause, distribution and firm actions are available in Orca1.

Source: U.S. Food and Drug Administration (FDA), Medical Device Recalls database

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