Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

Light Sheer Desire Diode Laser System with XC Handpiece Accessory options. Recalled by Lumenis Limited Due to Device software treatment preset parameters for the XC...

Date: March 25, 2015
Company: Lumenis Limited
Status: Terminated
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Lumenis Limited directly.

Affected Products

Light Sheer Desire Diode Laser System with XC Handpiece Accessory options.

Quantity: 117 units

Why Was This Recalled?

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.

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Lumenis Limited

Lumenis Limited has 3 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report