DEKA LIPOAI M131A1Recalls & reported problems
El.En. SPA · The LipoAI is medical laser equipped with a short pulse 1444 nm Nd:YAG laser source. The device delivers the laser energy through a 600 um optical fiber. The fiber is protected by a small stainless-steel cannula (max. 1.4mm) and is inserted in the tissue through a small aperture in the skin. · Class 2
Data updated Oct 13, 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 08057017760580), received between Aug 4, 2025 and Aug 4, 2025 — classified as 1 injury.
The most frequently reported specific device problem is “Use of Incorrect Control/Treatment Settings” (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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Use of Incorrect Control/Treatment Settings1
Patient problems
- Full thickness (Third Degree) Burn1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryAug 4, 2025Use of Incorrect Control/Treatment Settings; Use of Incorrect Control/Treatment Settings
IN DATE JULY THE 9TH 2025 WE RECEIVE A COMMUNICATION FROM THE US IMPORTER, (B)(6) RELATIVE TO AN ADVERSE EVENT IN WHICH A PATIENT DEVELOPED BURNS ON THE CHEST FOLLOWING A LASER LIPOLYSIS TREATMENT WITH THE DEVICE LIPO AI. THE ACTUAL DEVICE INVOLVED IN THE EVENT IS A LIPO AI, MANUFACTURED BY (B)(6) ELECTRONIC ENGINEERING SPA, MARKETED IN THE USA WITH 510(K) K212270. THE US IMPORTER, IN THE NARRATIVE AND INVESTIGATION PROVIDED WITH THE EVENT, REPORTED THE FOLLOWING: THE TREATMENT WAS PERFORMED IN DATE (B)(6) 2025. THE PARAMETERS USED FOR THE TREATMENT WERE 4887 JOULES DELIVERED ON EACH SIDE. 300MJ AND 40HZ (12 POWER AND LOW WERE LISTED ON THE OP NOTES). IT IS REPORTED THAT GLANDS HAVE BEEN REMOVED MANUALLY. PICTURES OF THE PATIENT WERE TAKEN THE DAY AFTER THE TREATMENT SHOWED SOME DARKENING UNDER THE TAPE. 4 DAYS AFTER TREATMENT THE PATIENT REMOVED THE TAPING THAT REVEALED FULL THICKNESS BURNS. IMMEDIATELY AFTER THE TREATMENT THE AREA WAS NOT FOUND WARM OR HOT. AS POST TREATMENT CARE THE PATIENT WAS INSTRUCTED TO NOT USE ANY GARMENT. WE, THE MANUFACTURER OF THE DEVICE, EVALUATED THE EVENT AS REPORTABLE UNDER 21 CFR PART 803 DUE TO THE FACT THAT THE LESION REPORTED BY THE PATIENT ARE
Patient problems: Full thickness (Third Degree) Burn
MAUDE report 22697367 ↗
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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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