Lumenis Inc. Lumenis brand Atlas, Corium, Elite, Elite Ultra 532nm Laser Systems; Manufactured before November 4, 2003; Manufactured by Lumenis, Inc., 3959 West 1820 South, Salt Lake City, Utah 84104 Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Lumenis brand Atlas, Corium, Elite, Elite Ultra 532nm Laser Systems; Manufactured before November 4, 2003; Manufactured by Lumenis, Inc., 3959 West 1820 South, Salt Lake City, Utah 84104
Brand
Lumenis Inc.
Lot Codes / Batch Numbers
All codes manufactured prior to November 4, 2003.
Products Sold
All codes manufactured prior to November 4, 2003.
Lumenis Inc. is recalling Lumenis brand Atlas, Corium, Elite, Elite Ultra 532nm Laser Systems; Manufactured before November 4, due to The BP/Notch filter may be out of specification and may cause injury to the patient's eye due to high power (energy) delivered by the Laser System dur. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
The BP/Notch filter may be out of specification and may cause injury to the patient's eye due to high power (energy) delivered by the Laser System during medical procedures.
Recommended Action
Per FDA guidance
On 7/26/04 and 2/1/06 the firm initiated the recall and its notification was via letters explaining the reason for the recall and requesting the product be returned for correction.
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