FDA Medical Device Recalls (openFDA)
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 number
- Z-0556-06
- Recalling firm
- Lumenis Inc.
- Product
- Lumenis brand LightSheer Pulsed Diode Array Laser System; All serial numbers; Manufactured by RH USA, Inc., 201 Lindbergh Avenue, Livermore, California 94551
- Status
- Terminated
- Initiated
- 2006-02-09
- Posted
- 2006-02-23
- Terminated
- 2006-08-28
- Reason
- During hair removal treatment, patients' skin can experience burns due to debris accumulating on the sapphire crystal tip.
- Root cause
- Other
- Action
- 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.
- Quantity
- 3,426 units
- Distribution
- The product was released for distribution to 3,426 consignees nationwide. There are 48 international consignees.
- Lot, serial or model codes
- All codes, All serial numbers
- 510(k) numbers
- ["K003614"]
- PMA numbers
- not on file
- Product code
- GEX
- Firm FEI
- 2914019
- Firm city
- Santa Clara
- Firm state
- CA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28