ALMA HARMONY CONSOLE 1Recalls & reported problems

Data updated Oct 16, 2026 from official FDA records · Editorial policy

Adverse event reports: 1
Deaths reported: 0
Injuries reported: 1
Recalls naming it: 0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 07290110123376), received between Sep 19, 2025 and Sep 19, 2025 — classified as 1 injury.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (1 report).

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 16, 2026.

Reports received per month

Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

Insufficient Device Problem Information1

Patient problems

Burn(s)1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

InjurySep 19, 2025Insufficient Device Problem Information; Insufficient Device Problem Information
A USER FACILITY REPORTED THAT ONE OF THEIR STAFF MEMBERS EXPERIENCED A BURN AT THE TREATMENT SITE DURING SELF USE OF THE ALMA HARMONY SYSTEM.
Patient problems: Burn(s)
MAUDE report 23097122 ↗

Device details

UDI-DI	`07290110123376`
Brand	ALMA HARMONY CONSOLE
Model	1
Catalog no.	AAHG25102201BR0001
Company	Alma Lasers Ltd.
Product code	GEX · Powered Laser Surgical Instrument
Class	Class 2
FDA submission	None listed
Implant	No
Rx / OTC	—
Single use	No
Sterile	No
MRI safety	Labeling does not contain MRI Safety Information
Status	In Commercial Distribution
Record updated	Jan 22, 2026

Device type (GMDN): Multi-modality skin surface treatment system

An electrically-powered assembly of devices intended to use multiple therapeutic modalities [e.g., intense pulsed light (IPL), laser, radio-frequency (RF) energy, microcurrent electrotherapy, electronic muscle stimulation (EMS), microdermabrasion, hydradermabrasion, oxygen skin application] in combination and/or in isolation for ablative and non-ablative treatment of the skin surface (e.g., removal of pigment/vascular lesions, scarring, acne, psoriasis, wrinkles, tattoos, hair, and skin resurfacing and rejuvenation). The system includes energy/therapy sources (e.g., lasers, lamps, generator) and dedicated applicators (handpieces) intended to apply the different therapies to the skin.

Other Powered Laser Surgical Instrument devices

Moxy 0010-2400
Boston Scientific Corporation · Powered Laser Surgical Instrument
4,572 reports
SOLTIVE TFL-PLS
Gyrus ACMI, LLC · Powered laser surgical instrument
6 recalls450 reports
Flexiva TracTip M0068403960
Boston Scientific Corporation · Powered laser surgical instrument
562 reports
Moses™ AC-10030100
Lumenis Ltd. · Powered Laser Surgical Instrument
532 reports
Flexiva M0068403910
Boston Scientific Corporation · Powered laser surgical instrument
376 reports
Visualase 9735542
Medtronic Navigation, Inc. · Powered laser surgical instrument
1 recall2 deaths311 reports
SOLTIVE TFL-SLS
Gyrus ACMI, LLC · Powered laser surgical instrument
6 recalls33 reports
NeuroBlate® System 20980
Monteris Medical Inc · Powered laser surgical instrument
7 deaths296 reports

All Powered Laser Surgical Instrument devices →

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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.

How reports and recalls are matched · Editorial policy · Report an error on this page