ASSY, FINAL LASER, PICO300 100-7051-010Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 00841494100537), received between Oct 4, 2022 and Jun 12, 2026 — classified as 5 injuries, 7 malfunctions.

The most frequently reported specific device problem is “Unexpected/Unintended Radiation Output” (6 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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 12, 2026Unexpected/Unintended Radiation Output

  IT WAS REPORTED THAT A PICOSURE PRO DEVICE DISCHARGED LASER ENERGY UNINTENTIONALLY AFTER THE FOOTSWITCH CABLE BECAME TRAPPED BENEATH A LASER CASTER WHEEL. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25487085 ↗
• MalfunctionJun 11, 2026Unexpected/Unintended Radiation Output

  IT WAS REPORTED THAT SITE HAD ENCOUNTERED F152 COMMUNICATION FAULT ERRORS WHILE USING PICOSURE PRO AND THAT THE FOOT PEDAL WOULD FIRE EVEN AFTER FOOT WAS OFF THE PEDAL. ERROR WITH 1064NM HANDPIECE (HP) WAS SHOWING TOO HIGH OR TOO LOW ENERGY, WITH SITE HAVING TO RECALIBRATE IT MULTIPLE TIMES FOR IT TO OPERATE. ERROR WITH 755NM ZOOM HP HAD THE SCREEN GLITCHING AND REQUIRED SITE TO RECALIBRATE AND RESTART REPEATEDLY. ERROR WITH 532NM HP NEEDED TO BE RECALIBRATED 10 TIMES BEFORE SITE WAS ABLE TO USE IT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25472404 ↗
• MalfunctionMay 5, 2026Unexpected/Unintended Radiation Output

  SITE CONTACTED CYNOSURE LUTRONIC TECHNICAL SUPPORT FOR ASSISTANCE WITH A LAMP WARNING MESSAGE ON THE PICOSURE PRO DEVICE. SITE THEN RELAYED TO TECHNICAL SUPPORT THAT A WEEK AGO, THE DEVICE WOULD NOT STOP FIRING EVEN AFTER OPERATOR TOOK HER FOOT OFF THE PEDAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25081191 ↗
• MalfunctionNov 14, 2025No Apparent Adverse Event; Insufficient Device Problem Information; No Apparent Adverse Event; Insufficient Device Problem Information

  SITE REPORTED THAT DURING A PICOSURE PRO LASER TATTOO REMOVAL TREATMENT A DISPLAY ERROR CODE APPEARED. THE ERROR CODE INDICATED HANDPIECE WAS UNRECOGNIZED. PROVIDER SWITCHED TO THE ZOOM HANDPIECE AND SAME ERROR CODE APPEARED. UPON RESTART, A SPARK OCCURRED EMITTING A BURNING-PLASTIC ODOR FOLLOWED BY PROVIDER EXPERIENCING AN ELECTRICAL SHOCK AND POTENTIAL BURN TO THE PATIENT.

  Patient problems: Electric Shock; No Clinical Signs, Symptoms or Conditions

  MAUDE report 23558729 ↗
• MalfunctionOct 20, 2025Unexpected/Unintended Radiation Output; Unexpected/Unintended Radiation Output

  IT WAS REPORTED THAT PICOSURE PRO DEVICE WAS NOT GOING INTO READY MODE SO SITE REACHED OUT TO CYNOSURE TECHNICAL SUPPORT FOR ASSISTANCE. A FIELD SERVICE ENGINEER (FSE) ARRIVED ONSITE TO HELP SITE WITH THEIR DEVICE PROBLEM. DURING EVALUATION, FSE OBSERVED LASER WOULD SOMETIMES CONTINUE TO FIRE EVEN AFTER FOOT PEDAL WAS RELEASED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23337434 ↗
• InjuryJul 23, 2025Unexpected/Unintended Radiation Output; Unexpected/Unintended Radiation Output

  SITE REPORTED PICOSURE PRO WAS FIRING LASER FOR A FEW SECONDS EVEN AFTER FOOT PEDAL WAS RELEASED. DEVICE REBOOTED ITSELF AND ATLEAST FIVE (5) ERROR MESSAGES APPEARED. SITE THEN SHUT DOWN THE DEVICE MANUALLY AND WAITED A FEW MINUTES BEFORE TURNING IT ON AGAIN. THE DEVICE THEN COULD NOT RECOGNIZE ANY OF THE HANDPIECES. SITE RESTARTED THE DEVICE AGAIN AND WAS NOW WORKING BUT STILL REPORTED ISSUES WITH FOOT PEDAL FIRING CONTINUOUSLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22580097 ↗
• InjuryJul 3, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT PATIENT EXPERIENCED BLISTER ON THE UPPER ARM FOLLOWING A LASER TATTOO REMOVAL TREATMENT USING PICOSURE PRO.

  Patient problems: Full thickness (Third Degree) Burn

  MAUDE report 19666562 ↗
• MalfunctionJul 3, 2024Unexpected/Unintended Radiation Output; Unexpected/Unintended Radiation Output

  IT WAS REPORTED THAT PICOSURE PRO WAS FIRING ON ITS OWN WITHOUT OPERATOR PRESSING ONTO THE FOOT PEDAL. SITE THEN RESTARTED THE SYSTEM AND LASER WAS FIRING PERFECTLY WITHOUT ISSUES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19666152 ↗
• InjuryDec 27, 2023Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT PATIENT EXPERIENCED FROSTING ON VARIOUS BODY AREAS FOLLOWING A TATTOO REMOVAL TREATMENT USING PICOSURE PRO.

  Patient problems: Burn(s)

  MAUDE report 18397632 ↗
• InjuryOct 20, 2023Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT PATIENT WAS TREATED FOR PIGMENTED LESIONS ON THE FOREHEAD USING PICOSURE PRO. PHYSICIAN WHO PERFORMED THE TREATMENT ACCIDENTALLY SHOT THE PATIENT'S EYEBROW. SHOT RESULTED IN HAIR LOSS ON THE EYEBROWS AREA.

  Patient problems: Hair Loss

  MAUDE report 17977762 ↗
• InjurySep 1, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT EXPERIENCED A BLISTER ON THE RIGHT ANKLE FOLLOWING A LASER TATTOO REMOVAL TREATMENT USING PICOSURE PRO. BLISTER OCCURRED 2 DAYS POST TREATMENT.

  Patient problems: Blister

  MAUDE report 17669508 ↗
• MalfunctionOct 4, 2022Radiation Output Problem; Radiation Output Problem

  IT WAS REPORTED THAT THE PICOSURE WAS CONTINUOUSLY FIRING DURING TREATMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15536345 ↗