LightSheer Duet ET HandpieceRecalls & reported problems
Lumenis Ltd. · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 3
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 07290109143057), received between Aug 26, 2021 and Dec 25, 2023 — classified as 3 injuries.
The most frequently reported specific device problem is “Missing Information” (2 reports).
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem3
- Missing Information2
Patient problems
- Burn(s)3
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
InjuryDec 25, 2023Adverse Event Without Identified Device or Use Problem; Missing Information; Adverse Event Without Identified Device or Use Problem; Missing Information
LUMENIS RECEIVED AN ADVERSE EVENT REPORT ON A PATIENT WHO SUSTAINED INJURY FOLLOWING TREATMENT BY LS QUATTRO DEVICE.
Patient problems: Burn(s)
MAUDE report 18390219 ↗InjuryDec 14, 2023Adverse Event Without Identified Device or Use Problem; Missing Information; Adverse Event Without Identified Device or Use Problem; Missing Information
LUMENIS RECEIVED AN ADVERSE EVENT REPORT ON A PATIENTS WHO SUSTAINED INJURY FOLLOWING TREATMENT BY LS DUET DEVICE.
Patient problems: Burn(s)
MAUDE report 18324097 ↗InjuryAug 26, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
LUMENIS RECEIVED AN ADVERSE EVENT REPORT ON A PATIENT WHO SUSTAINED BURN FOLLOWING TREATMENT BY HANDPIECE ET OF THE LIGHTSHEER DUET DEVICE.
Patient problems: Burn(s)
MAUDE report 12369650 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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