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CO2 New Scanner system 100-120V 30WRecalls & reported problems

Alma Lasers Ltd. · Class 2

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 17290110120952), received between Jun 28, 2018 and Jan 8, 2025 — classified as 3 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (3 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. How this data works · Data updated Oct 13, 2026.

Reports received per month

Nov 2023: 0 reportsDec 2023: 0 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: 1 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 reports2024202520261
Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

  • Insufficient Device Problem Information3

Patient problems

  • Burn(s)1
  • Herpes1
  • Pain1
  • Scar Tissue1

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

  • InjuryJan 8, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

    THE PATIENT SUBMITTED A SELF REPORT (MW5162379) TO FDA ABOUT A SCAR TISSUE FOLLOWING THE PIXEL CO2 TREATMENT ON 2021.

    Patient problems: Pain; Scar Tissue

    MAUDE report 21101000 ↗
  • InjuryMar 28, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

    AS PER THE FACILITY, THE PATIENT SUSTAINED SLIGHT BURNS ON THE EXTERNAL LABIA.

    Patient problems: Burn(s)

    MAUDE report 8460606 ↗
  • InjuryJun 28, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

    THE SUSPECTED DEVICE WAS USED ON PATIENT'S NECK, FACE AND CHEST. AS PER THE FACILITY, THE ALLEGED INJURY WAS DIAGNOSED AS COLD SORES ON FACE AND NECK. THE FACILITY DID NOT PROVIDE ANY TREATMENT/HANDPIECE DETAILS AND WAS UNRESPONSIVE TO ALMA'S MULTIPLE ATTEMPTS TO OBTAIN INFORMATION.

    Patient problems: Herpes

    MAUDE report 7648048 ↗

Other Laser, Ophthalmic devices

All Laser, Ophthalmic devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.