Soprano Titanium System 230V 1Recalls & reported problems
Alma Lasers Ltd. · The Alma Lasers Soprano Titanium Laser System consists of: •System console (contains the laser diodes, the system software, power supply, andvarious other electronic and mechanical parts) •Operator control panel with touch-screen technology (GUI) •Trio applicator with 1064 nm, 810 nm and 755 nm wavelengths applied simultaneously Premarket Notification Traditional 510(k) Section 8: Page 2 of 4 Alma Lasers Soprano Titanium • 810 nm applicator • 755 nm applicator • Small NIR applicator • Footswitch and other laser safety accessories · Class 2
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 7
- Deaths reported
- 0
- Injuries reported
- 7
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 17290110121829), received between Apr 26, 2024 and Jul 11, 2025 — classified as 7 injuries.
The most frequently reported specific device problem is “Use of Device Problem” (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
Most reported problems
Device problems
- Use of Device Problem3
- Improper or Incorrect Procedure or Method2
- Use of Incorrect Control/Treatment Settings2
Patient problems
- Burn(s)5
- Blister2
- Hyperpigmentation1
- Scar Tissue1
Recent adverse event reports
The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.
InjuryJul 11, 2025Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method
THE IMPORTER REPORTED THAT USER FACILITY REPORTED THAT A PATIENT EXPERIENCED A BLISTER POST SOPRANO TITANIUM TREATMENT.
Patient problems: Blister
MAUDE report 22480065 ↗InjuryJun 10, 2025Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method
InjuryMar 27, 2025Use of Incorrect Control/Treatment Settings; Use of Incorrect Control/Treatment Settings
A USER FACILITY REPORTED THAT A PATIENT EXPERIENCED WHAT APPEARS TO BE A THIRD-DEGREE BURN AT THE TREATMENT SITE FOLLOWING THE USE OF THE SOPRANO TITANIUM SYSTEM.
Patient problems: Burn(s); Hyperpigmentation
MAUDE report 21712546 ↗InjuryJun 12, 2024Use of Incorrect Control/Treatment Settings; Use of Incorrect Control/Treatment Settings
IT WAS REPORTED ABOUT A BURN ON RIGHT SIDE OF THE NECK AFTER THE SOPRANO TITANIUM HAIR REMOVAL TREATMENT.
Patient problems: Burn(s); Scar Tissue
MAUDE report 19516775 ↗InjuryMay 6, 2024Use of Device Problem; Use of Device Problem
IT WAS REPORTED ABOUT A BURN AFTER THE SOPRANO TITANIUM TREATMENT.
Patient problems: Burn(s)
MAUDE report 19246337 ↗InjuryApr 26, 2024Use of Device Problem; Use of Device Problem
IT WAS REPORTED ABOUT A BURN ON THE NECK AFTER THE SOPRANO TITANIUM TREATMENT.
Patient problems: Burn(s)
MAUDE report 19194101 ↗InjuryApr 26, 2024Use of Device Problem; Use of Device Problem
IT WAS REPORTED ABOUT A BURN AFTER THE SOPRANO TITANIUM TREATMENT.
Patient problems: Burn(s)
MAUDE report 19193634 ↗
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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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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