Lumenis

LIGHTSHEER DESIRE, serial all systems with XC handpiece.

Destined for temporary hair removal, or long-term or permanent hair reduction, by selective application to melanin of the hair follicles. Used for pseudofolliculitis, treatment of varicose veins, benign vascular lesions, angiomas, hemangiomas and telangiectasia

AcuPulse DUO CO2, AcuPulse and AcuScan120, concerning the FemTouch Kit and FemTouch Handpiece systems.

The CO2 laser can be used effectively in soft tissue removal, incision, ablation, vaporization and coagulation. This CO2 laser system excited by DC (direct current) is designed for various procedures, aesthetic, surgical and general surgery.

Pulse Holmium · Yag Laser

Model: All models, Affected: All lots

GA-0007500 (VersaCut + System with Inverted H/P) and GA-0007600 (VersaCut + System with Regular H/P). Only the hand pieces for the system (SA4769200 inverted HP, SA4768700 regular HP) are affected by this recall.

General and Plastic Surgery Devices

2

No

Worldwide Distribution - US including CA, PA, MA, FL, and NY, and Internationally to Italy, Germany, Australia, China, Great Britian, United Kingdom, Taiwan, France, Peru, Mexico, Turkey, Spain, and Russia.

Lumenis VersaCut+ Tissue Morcellator GA-0007500 || The Lumenis VersaCut / VersaCut+ Tissue Morcellator System is intended for use under direct or endoscopic visualization for the morcellation and removal of dissected tissue during pelviscopic, laparoscopic, percutaneous, and open surgical procedures whenever access to the surgical site is limited.