Legend ProRecalls & reported problems
Pollogen Ltd · LEGEND PRO PACKED Applicators 1-3 provide RF energy that heats biological tissue in a controlled fashion for non-ablative therapeutic effects. Non ablative effects are used to trigger collagen remodeling for the treatment of wrinkles and rhytides. Applicator No. 1 is indicated for the treatment of large facial areas. It is connected to the main unit by a cable containing electrical wiring and a connector, consists of a plastic body with an integrated electronic system, 6 electrodes and indication light guide ring. · Class 2
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 07290016586138), received between Apr 21, 2021 and Apr 21, 2021 — 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.
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.
InjuryApr 21, 2021Insufficient Device Problem Information; Insufficient Device Problem Information
LUMENIS RECEIVED AN ADVERSE EVENT REPORT ON A PATIENT WHO SUSTAINED BURNS FOLLOWING TREATMENT BY LEGEND PRO DEVICE. DESCRIBED HEAT AS BEING HOTTER THAN A SUNBURN AND WAS IN PAIN. ADVISED CLIENT TO PUT ICE. PATIENT WAS VERY PINK AND SWOLLEN AND SHOWED SIGNS OF A SEVERE HISTAMINE RESPONSE AND POSSIBLE ALLERGIC REACTION. THE CUSTOMER SPOKE TO THE PATIENT EVERY DAY DURING WEEK MONDAY - FRIDAY. ON FRIDAY IT WAS STILL SWOLLEN AND WAS EXPERIENCING ITCHINESS AND PAIN.
Patient problems: Burn(s)
MAUDE report 11702056 ↗
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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 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.
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