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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

Nov 2023: 0 reportsDec 2023: 2 reportsJan 2024: 0 reportsFeb 2024: 0 reportsMar 2024: 0 reportsApr 2024: 0 reportsMay 2024: 0 reportsJun 2024: 0 reportsJul 2024: 0 reportsAug 2024: 0 reportsSep 2024: 0 reportsOct 2024: 0 reportsNov 2024: 0 reportsDec 2024: 0 reportsJan 2025: 0 reportsFeb 2025: 0 reportsMar 2025: 0 reportsApr 2025: 0 reportsMay 2025: 0 reportsJun 2025: 0 reportsJul 2025: 0 reportsAug 2025: 0 reportsSep 2025: 0 reportsOct 2025: 0 reportsNov 2025: 0 reportsDec 2025: 0 reportsJan 2026: 0 reportsFeb 2026: 0 reportsMar 2026: 0 reportsApr 2026: 0 reportsMay 2026: 0 reportsJun 2026: 0 reportsJul 2026: 0 reportsAug 2026: 0 reportsSep 2026: 0 reportsOct 2026: 0 reports2024202520262
Last 36 months. The most recent month may be incomplete.

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

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