Recall Z-0691-2013— Quanta System, S.p.A.
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 2 FDA 510(k) clearances: K123168, K073549. Product: 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: 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
2 on FDA's recordK-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
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.