Lumenis Inc. Lumenis brand LightSheer Pulsed Diode Array Laser System; All serial numbers; Manufactured by RH USA, Inc., 201 Lindbergh Avenue, Livermore, California 94551 Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Lumenis brand LightSheer Pulsed Diode Array Laser System; All serial numbers; Manufactured by RH USA, Inc., 201 Lindbergh Avenue, Livermore, California 94551
Brand
Lumenis Inc.
Lot Codes / Batch Numbers
All codes, All serial numbers
Products Sold
All codes, All serial numbers
Lumenis Inc. is recalling Lumenis brand LightSheer Pulsed Diode Array Laser System; All serial numbers; Manufactured by RH USA due to During hair removal treatment, patients' skin can experience burns due to debris accumulating on the sapphire crystal tip.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
During hair removal treatment, patients' skin can experience burns due to debris accumulating on the sapphire crystal tip.
Recommended Action
Per FDA guidance
On 2/9/06, the firm initiated the recall and its notification was via letters informing its customers of the corrective action. In May 2005, Lumenis mailed a 'Dear Doctor' letter to LightSheer Diode Laser System customers describing more detailed cleaning procedures to be used on the sapphire tips due to skin burns patients' were experiencing from debris build-up on the tip.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026