GentleMax Pro 9914-00-9035Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00817495020013), received between Sep 29, 2016 and Jul 11, 2025 — classified as 8 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Component Falling” (2 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 16, 2026.

Most reported problems

Recent adverse event reports

The 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 11, 2025Fire; Fire

  ON JUNE 12TH, 2025, CANDELA CORPORATION BECAME AWARE OF A FIRE REPORTED BY A CUSTOMER IN JAPAN. THE FIRE INVOLVED CANDELA GENTLEMAX PRO DEVICE, SERIAL NUMBER: (B)(6). THERE WERE NO INJURIES TO PATIENTS, PROVIDERS, NOR CLINIC STAFF. A NURSE AT THE CUSTOMER SITE CALLED A CANDELA FIELD SERVICE ENGINEER TO REPORT THAT THERE WAS A "CLAPPING NOISE" FROM MACHINE DURING IRRADIATION. THERE WERE NO DEVICE FAULT CODES, ALARMS, OR ERROR MESSAGES DISPLAYED. DURING THE CALL, SMOKE CAME OUT OF THE MACHINE AND THE FIRE ALARM IN THE CLINIC WENT OFF. THE CLINIC OWNER INSTRUCTED EVERYONE (PATIENT, DOCTOR, NURSES, STAFF, ETC.) TO EVACUATE THE BUILDING. WHEN THE FIRE DEPARTMENT ARRIVED, IT WAS ALLEGED THAT THE "MACHINE CAUSED A FIRE." THE DEVICE WAS REMOVED FROM THE CLINIC TO BE EVALUATED BY A THIRD PARTY, AND IS NOW ENROUTE TO CANDELA HEADQUARTERS, MARLBOROUGH, MASSACHUSETTS, USA FOR ADDITIONAL TESTING AND FAILURE ANALYSIS. THE COMPLAINT INVESTIGATION IS PENDING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22478208 ↗
• MalfunctionFeb 20, 2019Sparking; Flare or Flash; Sparking; Flare or Flash

  ON (B)(6) 2018 A DERMATOLOGY CLINIC REPORTED OBSERVING A SPARK. DURING ROUTINE FOLLOW UP THE CLINIC DIRECTOR REPORTED ON (B)(6) 2019 IN ADDITION TO A SPARK, AN UNSUSTAINED FLAME WAS OBSERVED ORIGINATING FROM THE DEVICE FIBER CABLE DURING TREATMENT. THE FIBER WAS CONNECTED TO A GMAX-PRO LASER. IT WAS ALSO REPORTED BY THE CLINIC DIRECTOR THAT THERE WAS NO REPORTED PATIENT IMPACT AND NO SUSTAINED FIRE. ADDITIONAL INFORMATION WAS SOLICITED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8353552 ↗
• InjuryMay 10, 2018Detachment Of Device Component; Component Falling

  ON (B)(6) 2018 THE (B)(6) DERMATOLOGY ACCOUNT IN THE US REPORTED THAT DURING THE LASER TREATMENT, THE LANS FROM THE HAND PIECE FELL OUT AND BURNED THE PATIENT.

  Patient problems: Partial thickness (Second Degree) Burn

  MAUDE report 7503413 ↗
• InjuryApr 18, 2018Insufficient Device Problem Information

  ON (B)(6) 2018 A PATIENT THAT WAS TREATED BY (B)(6) IN (B)(6) REPORTED THAT THEY RESPONDED TO LASER TREATMENT WITH BURNS.

  Patient problems: Partial thickness (Second Degree) Burn

  MAUDE report 7441306 ↗
• InjuryApr 11, 2018Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2018, THE ADVANCED CARDIOVASCULAR CARE ACCOUNT IN US REPORTED THAT PATIENTS RESPONDED TO LASER TREATMENT WITH BURNS.

  Patient problems: Partial thickness (Second Degree) Burn

  MAUDE report 7422807 ↗
• InjuryApr 5, 2018Component Falling

  ON (B)(6) 2018, THE ACCOUNT IN (B)(6) REPORTED AN INJURY TO PATIENT AFTER LASER TREATMENT. THE OFFICE REPORTED THAT " WINDOW FELL OUT FROM THE HANDPIECE ON PATIENT CREATING BURN". THIS OFFICE REPORTED THAT PATIENT CONDITION WAS OK AND "PATIENT IS HEALING" .

  Patient problems: Partial thickness (Second Degree) Burn

  MAUDE report 7400155 ↗
• InjuryFeb 27, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON FEBRUARY 6, 2018, THE ACCOUNT (B)(6) REPORTED THAT THEIR PATIENT RECEIVED LASER TREATMENT ON (B)(6) 2018 AND RESPONDED WITH BURNS AND BLISTERS ON TREATED AREA.

  Patient problems: Partial thickness (Second Degree) Burn

  MAUDE report 7301292 ↗
• InjurySep 14, 2017Insufficient Device Problem Information

  ON (B)(6) 2017, THE (B)(6) ACCOUNT IN THE US REPORTED ON A SITUATION WHERE A PATIENT RECEIVED LASER TREATMENT AND RESPONDED WITH A BURN ON THE TREATED AREA.

  Patient problems: Burn(s)

  MAUDE report 6867029 ↗
• InjuryJul 27, 2017Improper or Incorrect Procedure or Method

  ON (B)(6)2017, (B)(6) LOCATED IN (B)(67) REPORTED THAT THERAPIST (THE HEAD OF THE CLINIC) FIRED LASER PULSE TOWARD HER EYES AREA.

  Patient problems: Blurred Vision

  MAUDE report 6748661 ↗
• InjurySep 29, 2016Adverse Event Without Identified Device or Use Problem; Appropriate Device Problem Term/Code Not Available; Adverse Event Without Identified Device or Use Problem; Appropriate Device Problem Term/Code Not Available

  THE ATTENDING PHYSICIAN REPORTED ON A SITUATION WHERE A PATIENT RECEIVED LASER TREATMENT FOR LEG VEINS (TELANGIECTASIA). THE PATIENT RESPONDED WITH RING SHAPED BURNS IN THE TREATED AREA. AFTER 10 DAYS, DEEP NECROSIS INCLUDING SUBCUTIS FATTY TISSUE IN THE TREATED AREA WAS OBSERVED. THE PATIENT WAS RECEIVING TREATMENT FOR THE WOUND BY THE ATTENDING PHYSICIAN. THE WOUND HAS BEEN REPORTED HEALED AS OF (B)(6) 2016. THE PHYSICIAN CONTINUED TO ATTEND TO THE PATIENT UNTIL THE WOUND WAS HEALED. SINCE THIS PATIENT WAS TREATED IN (B)(6) AND THE TREATMENT DATA ENCODED IN THE SOFTWARE DOWNLOADED IN MID- (B)(6); WE DID NOT RETRIEVE ANY DATA THAT COULD HELP WITH THE INVESTIGATION. TECHNICAL EVALUATION OF THE DEVICE IS NEEDED TO RULE OUT EQUIPMENT MALFUNCTION.

  Patient problems: Burn(s); Full thickness (Third Degree) Burn

  MAUDE report 5987776 ↗