Stellar M22Recalls & reported problems
Lumenis Ltd. · Class 2
Quick summary
This Lumenis Stellar M22 is a laser and light-based device used for skin treatments such as facial and pigmentation procedures. It has 23 adverse event reports, all involving injuries — mostly burns to patients during treatment, with some reports describing a strong flash, unusual noise, or an error code before the burn; no deaths have been reported. No recalls name this device.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 22
- Deaths reported
- 0
- Injuries reported
- 22
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 22 adverse event reports that list this exact device (DI 07290109144726), received between Feb 14, 2021 and Aug 9, 2026 — classified as 22 injuries.
The most frequently reported specific device problem is “Defective Component” (4 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
- Adverse Event Without Identified Device or Use Problem6
- Defective Component4
- Use of Device Problem4
- Use of Incorrect Control/Treatment Settings4
- Insufficient Device Problem Information3
- No Apparent Adverse Event1
Patient problems
- Burn(s)20
- Insufficient Information2
- Skin Erosion1
- Skin Inflammation/ Irritation1
Recent adverse event reports
The 22 most recent of 22 reports, in the reporter's own words as published by the FDA.
InjuryAug 9, 2026Use of Incorrect Control/Treatment Settings
Lumenis received an adverse event report on a patient who sustained injury following treatment by the Stellar device.
Patient problems: Burn(s)
MAUDE report 50188829 ↗InjuryMay 26, 2026Insufficient Device Problem Information
LUMENIS RECEIVED AN ADVERSE EVENT REPORT ON A PATIENT WHO SUSTAINED INJURY FOLLOWING TREATMENT BY STELLAR DEVICE. PER THE CUSTOMER, PATIENT HAD MELASMA TREATMENT AND SHE ENDED UP GETTING MORE PIGMENT (WORSE).
Patient problems: Insufficient Information
MAUDE report 25277614 ↗InjuryApr 19, 2026Defective Component
LUMENIS RECEIVED AN ADVERSE EVENT REPORT ON A PATIENT WHO SUSTAINED BURN FOLLOWING TREATMENT BY STELLAR DEVICE. ACCORDING TO THE CUSTOMER, THE ISSUE OCCURRED WHILE USING THE STELLAR M22, FACIAL A, 560 NM, AT 10 J. ON THE 17TH SHOT, AN UNUSUAL NOISE CAME FROM THE MAIN UNIT, FOLLOWED BY A STRONG FLASH. AFTER THE IRRADIATION, A BURN WAS OBSERVED. DUE TO THE BURN SYMPTOMS, THE PATIENT WAS EXAMINED AND OINTMENT WAS PROVIDED.
Patient problems: Burn(s)
MAUDE report 24921127 ↗InjuryApr 19, 2026Defective Component
LUMENIS RECEIVED AN ADVERSE EVENT REPORT ON A PATIENT WHO SUSTAINED BURN FOLLOWING TREATMENT BY STELLAR DEVICE. ACCORDING TO THE CUSTOMER, THE ISSUE OCCURRED WHILE USING THE STELLAR M22, FACIAL A, 560 NM, AT 10 J. ON THE 17TH SHOT, AN UNUSUAL NOISE CAME FROM THE MAIN UNIT, FOLLOWED BY A STRONG FLASH. AFTER THE IRRADIATION, A BURN WAS OBSERVED. DUE TO THE BURN SYMPTOMS, THE PATIENT WAS EXAMINED AND OINTMENT WAS PROVIDED.
Patient problems: Burn(s)
MAUDE report 24921126 ↗InjuryMar 22, 2026Use of Incorrect Control/Treatment Settings
LUMENIS RECEIVED AN ADVERSE EVENT REPORT ON A PATIENT WHO SUSTAINED INJURY FOLLOWING TREATMENT BY THE STELLAR DEVICE.
Patient problems: Burn(s)
MAUDE report 24658127 ↗InjuryMar 15, 2026Defective Component
LUMENIS RECEIVED AN ADVERSE EVENT REPORT ON A PATIENT WHO SUSTAINED BURN FOLLOWING TREATMENT BY STELLAR DEVICE. PER THE CUSTOMER, THE FIRST PULSE DURING TREATMENT CREATED A STRONG FLASH AND IT BURNED THE PATIENT THEN THE ERROR CODE 1082 (SYSTEM FPGA FAULT) APPEARED ON THE SCREEN.
Patient problems: Burn(s)
MAUDE report 24601650 ↗InjuryMar 15, 2026Defective Component
LUMENIS RECEIVED AN ADVERSE EVENT REPORT ON A PATIENT WHO SUSTAINED BURN FOLLOWING TREATMENT BY STELLAR DEVICE. PER THE CUSTOMER, THE FIRST PULSE DURING TREATMENT CREATED A STRONG FLASH AND IT BURNED THE PATIENT THEN THE ERROR CODE 1082 (SYSTEM FPGA FAULT) APPEARED ON THE SCREEN.
Patient problems: Burn(s)
MAUDE report 24601649 ↗InjuryNov 10, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
LUMENIS RECEIVED AN ADVERSE EVENT REPORT ON SEVERAL PATIENTS WHO SUSTAINED SWELLING FOLLOWING TREATMENT BY STELLAR DEVICE. HOWEVER, SINCE THE CUSTOMER DIDN'T PROVIDE US EVEN ONE INCIDENT FORM, THIS CASE WILL BE EVALUATED IN CURRENT SINGLE COMPLAINT.
Patient problems: Insufficient Information
MAUDE report 23507765 ↗InjuryAug 25, 2025Use of Device Problem; Use of Device Problem
LUMENIS RECEIVED AN ADVERSE EVENT REPORT ON A PERSON WHO SUSTAINED INJURY FOLLOWING TREATMENT BY STELLAR DEVICE.
Patient problems: Burn(s)
MAUDE report 22882273 ↗InjuryAug 25, 2025Use of Device Problem; Use of Device Problem
LUMENIS RECEIVED AN ADVERSE EVENT REPORT ON A PERSON WHO SUSTAINED INJURY FOLLOWING TREATMENT BY STELLAR DEVICE.
Patient problems: Burn(s)
MAUDE report 22882258 ↗InjuryJul 1, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
LUMENIS RECEIVED AN ADVERSE EVENT REPORT ON A PATIENT WHO SUSTAINED INJURY ON THE LEFT LATERAL FOREHEAD USING IPL HANDPIECE FOLLOWING TREATMENT BY STELLAR DEVICE. THIS IS A SECOND INJURY OF THE SAME PATIENT (USER FACILITY HERSELF - DR. (B)(6)) THAT HAS BEEN HANDLED THROUGH COMPLAINT #(B)(4). THIS WAS DURING ANOTHER TREATMENT USING DIFFERENT SETTINGS ON A DIFFERENT DAY.
Patient problems: Burn(s)
MAUDE report 22369226 ↗InjuryJul 1, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
LUMENIS RECEIVED AN ADVERSE EVENT REPORT ON A PATIENT WHO SUSTAINED INJURY ON THE LEFT LATERAL FOREHEAD USING IPL HANDPIECE FOLLOWING TREATMENT BY STELLAR DEVICE. THIS IS A SECOND INJURY OF THE SAME PATIENT (USER FACILITY HERSELF - DR. (B)(6) THAT HAS BEEN HANDLED THROUGH COMPLAINT # (B)(4). THIS WAS DURING ANOTHER TREATMENT USING DIFFERENT SETTINGS ON A DIFFERENT DAY.
Patient problems: Burn(s)
MAUDE report 22369160 ↗InjuryJun 15, 2025Use of Device Problem; Use of Device Problem
LUMENIS RECEIVED AN ADVERSE EVENT REPORT ON A PATIENT WHO SUSTAINED INJURY USING IPL HANDPIECE FOLLOWING TREATMENT BY STELLAR DEVICE.
Patient problems: Burn(s)
MAUDE report 22208583 ↗InjuryJun 15, 2025Use of Device Problem; Use of Device Problem
LUMENIS RECEIVED AN ADVERSE EVENT REPORT ON A PATIENT WHO SUSTAINED INJURY USING IPL HANDPIECE FOLLOWING TREATMENT BY STELLAR DEVICE.
Patient problems: Burn(s)
MAUDE report 22208580 ↗InjuryJul 18, 2024Insufficient Device Problem Information; Insufficient Device Problem Information
LUMENIS RECEIVED AN ADVERSE EVENT REPORT ON A PATIENT WHO SUSTAINED BURN USING IPL HANDPIECE FOLLOWING TREATMENT BY STELLAR DEVICE.
Patient problems: Burn(s)
MAUDE report 19770786 ↗InjuryFeb 20, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
LUMENIS RECEIVED AN ADVERSE EVENT REPORT ON SEVERAL PATIENTS WHO SUSTAINED BURNS FOLLOWING TREATMENT BY STELLAR DEVICE. SINCE LUMENIS DIDN'T RECEIVE AN INCIDENT FORM, THIS CASE HANDLED AS ONE COMPLAINT.
Patient problems: Burn(s)
MAUDE report 18737572 ↗InjurySep 10, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
LUMENIS RECEIVED ON (B)(6), 2023 AN ADVERSE EVENT REPORT ON A PATIENT WHO SUSTAINED A BURN ON HER LEG WITH OPEN WOUND FOLLOWING TREATMENT BY STELLAR DEVICE. ACCORDING TO THE INFORMATION RECEIVED, THE EVENT OCCURRED ON (B)(6), 2022. LUMENIS CANNOT CONFIRM EVER RECEIVING NOTIFICATION OF THIS EVENT AT THAT TIME. SEE "COMPLAINT DESCRIPTION" ABOVE FOR THEIR FULL NOTIFICATION.
Patient problems: Burn(s); Skin Erosion; Skin Inflammation/ Irritation
MAUDE report 17716894 ↗InjuryApr 4, 2023No Apparent Adverse Event; No Apparent Adverse Event
LUMENIS RECEIVED AN ADVERSE EVENT REPORT ON SEVERAL PATIENTS WHO SUSTAINED BURNS FOLLOWING TREATMENT BY STELLAR DEVICE.
Patient problems: Burn(s)
MAUDE report 16674189 ↗InjuryMar 23, 2023Use of Incorrect Control/Treatment Settings; Use of Incorrect Control/Treatment Settings
LUMENIS RECEIVED AN ADVERSE EVENT REPORT ON A PATIENT WHO SUSTAINED BURN FOLLOWING TREATMENT BY STELLAR M22 DEVICE.
Patient problems: Burn(s)
MAUDE report 16596825 ↗InjuryMar 23, 2023Use of Incorrect Control/Treatment Settings; Use of Incorrect Control/Treatment Settings
LUMENIS RECEIVED AN ADVERSE EVENT REPORT ON A PATIENT WHO SUSTAINED BURN FOLLOWING TREATMENT BY STELLAR M22 DEVICE.
Patient problems: Burn(s)
MAUDE report 16596773 ↗InjuryAug 25, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
LUMENIS RECEIVED AN ADVERSE EVENT REPORT ON A PATIENT WHO SUSTAINED BURN FOLLOWING TREATMENT BY THE M22 STELLAR DEVICE.
Patient problems: Burn(s)
MAUDE report 15293087 ↗InjuryFeb 14, 2021Insufficient Device Problem Information; Insufficient Device Problem Information
LUMENIS RECEIVED AN ADVERSE EVENT REPORT ON A PATIENT WHO SUSTAINED BURNS ON AN UNKNOWN AREA FOLLOWING TREATMENT WITH A LUMENIS STELLAR DEVICE.
Patient problems: Burn(s)
MAUDE report 11325998 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.