FDAMarch 25, 2015device
Light Sheer Desire Diode Laser System with XC Handpiece Accessory options.
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
Device software treatment preset parameters for the XC treatment handpiece do not match the Operator Manual, and exceed recommended settings. Operator Manual parameters are lower than indicated for specific hair color and Fitzpatrick skin type resulting in insufficient treatment effect. May result in patient burns and hypopigmentation.
What to do
FDA enforcement status: Terminated
Brands named
lumenis
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
- FDAOtoLase Starter Kit; UPN: AC-2003748. Indicated for a variety of surgical uses including ablation, coagulation, incision, excision, and vaporization of soft tissue.2025-07-22
- FDA(1) Lumenis Pulse 120H 30 amp, REF GA 2009996, Laser System; (2) Lumenis Pulse 120H, Moses 2.0 (DOM), REF GA0006802, Laser System; and (3) Lumenis Pulse 120H, REF GA-0008700, Laser System.2025-01-23
- FDAIPL Coupling Gel, I L (AX1009013), 12 pack of 0.25 L (AX1009018), 6 pack of 1 L (AX1009019 or AX1009063); and IPL Coupling Gel or EcoGel 200, 0.25 L (AX1009012) manufactured by Eco-Med Pharmaceutical2021-10-14
- FDAFemTouch delivery system includes the FemTouch Kit (AC-1007415) and FemTouch" Tip (SPSA-20002590) Provide fractional treatments in gynecology.2016-09-25
- FDALumenis M22 System Model Number: GA-0005400 (M22 IPL + YAG Module) with Acne Filter (KT-1014971).2015-11-17
- FDALumenis 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...2015-07-30
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