Q-Plus T Powered Laser Surgical Instrument Nd:YAG 1064 nm and 532 nm

Product Description:

Q-Plus T Powered Laser Surgical Instrument Nd:YAG 1064 nm and 532 nm: Treatment of vascular lesions and pigmented lesions; Hair and tattoo removal; The incision, excision, ablation, vaporization of soft tissue for general dermatology. Ruby 694nm: Cutting, vaporization and ablation of soft tissue; Tattoo removal; Treatment of benign pigmented lesions.

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.

Product Quantity: 75 units

Recalling Firm:

Quanta System, S.p.A.
Via IV Novembre, 116
Solbiate Olona (VA)
Italy

Recall Initiation Date: 11/7/2012

Full Details:  https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=115258