Device 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
Z-0692-2013
Product summary
- Event
- Event 64039
- Status
- Terminated
- Classification
- Class II
- Quantity
- 12 units
- Official record key
device-enforcement:Z-0692-2013
Official wording
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.
Code information: All codes and devices are applicable.
Distribution pattern: Class II Recall - Worldwide Distribution - USA including TX, AZ, OR, and CO. Only US product is affected by this recall.
Derived failure modes
-
Unknown
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.