FDA Device recall Z-0693-2013
Ultrawave II EX 1320/ Ultrawave III EX 1320 Powered Laser Surgical Instrument
- FDA Device
- Class II
- terminated
- Published 2013-01-23
On 2013-01-23 the FDA classified a Class II recall of Ultrawave II EX 1320/ Ultrawave III EX 1320 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
| Agency | FDA Device |
|---|---|
| Recall number | Z-0693-2013 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2012-11-07 |
| Published | 2013-01-23 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Quanta System S P A |
| Distribution | AZ, CO, OR, TX |
Product
Ultrawave II EX 1320/ Ultrawave III EX 1320 Powered Laser Surgical Instrument. Nd:YAG 1064 nm: Coagulation and hemostasis of benign vascular lesions (e.g. port wine stains, hemangiomas, warts, telangiectasia, rosacea, venus lake, leg and spider veins, scars, straie and psoriasis; Treatment of benign pigmented lesions to reduce lesion size, for patients with lesions that would potentially benefit from aggressive treatment, and for patients with lesions that have not responded to other laser treatments; Treatment of facial wrinkles (e.g. periocular and periorbital); Removal of unwanted hair, for the stable longterm, or permanent, hair reduction, including Fitzpatrick IVI and suntanned skin types; For the treatment of pseudofolliculitis barbae (PFB); Reduction of red pigmentation in hypertrophic and keloid scars where vascularity is an integral part of the scar; For use on all skin types (Fitzpatrick IVI) including tanned skin. Alexandrite 755 nm: Coagulation and hemostasis of vascular lesions and the removal and permanent reduction of unwanted hair in Fitzpatrick skin types 1VI, including suntanned skin types; Pigmented lesions; Wrinkles. Nd: YAG 1320 nm: General surgery and dermatology for the incision, excision, ablation, vaporization, coagulation and hemostasis of soft tissue; Treatment of periorbital and periocular wrinkles, fine lines and wrinkles, treatment of back acne and atrophic acne scars. IPL: Permanent hair reduction; Photocoagulation of dermatological vascular lesion (i.e. face telangiectasia); Photothermolysis of blood vessels (treatment of facial and leg veins); 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.
Identifiers
| code_info | All 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-0693-2013%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.