GentleLASE Pro-U 9914-00-9030Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00817495020082), received between Mar 28, 2018 and Nov 23, 2022 — classified as 2 injuries.

The most frequently reported specific device problem is “Naturally Worn” (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 18, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryNov 23, 2022Naturally Worn; Patient Device Interaction Problem; Naturally Worn; Patient Device Interaction Problem

  A CUSTOMER IN SPAIN REPORTED THREE (3) STAFF MEMBERS (ESTHETICIANS) AT THE CLINIC HAD STINGING AND ITCHING EYES AFTER OPERATING THE GENTLELASEPRO U LASER.THERE WAS NO IMPACT NOR INJURY RELATED TO ANY PATIENT. PER FOLLOW-UP WITH CUSTOMER OFFICE MANAGER, IT WAS LEARNED THAT THE DEVICE WAS RECEIVED FROM CANDELA WITH APPROPRIATE PROTECTIVE EYEWEAR. HOWEVER, THE CUSTOMER HAS MOVED THE DEVICE BETWEEN CLINIC LOCATIONS.THE REPORTING CLINIC RECEIVED THE GENTLELASEPRO U LASER UNIT IN JULY OF 2022 "WITHOUT NEW PAIRS OF GOGGLES, SO THEY WERE USING OLD ONES." ADDITIONAL FOLLOW-UP INFORMATION WAS OBTAINED FROM THE CLINIC OFFICE MANAGER/ESTHETICIAN, INDICATING THAT THE EYE STINGING AND ITCHING "FIRST HAPPENED DURING JULY." SPECIFIC DATE IS UNKNOWN. CUSTOMER REPORTED THAT THEY THEN STOPPED WORKING DURING THE SUMMER TIME. THE OFFICE MANAGER SAID IT OCCURRED AGAIN ONCE THEY STARTED WORKING WITH THE LASER AGAIN, APPROXIMATELY 15 DAYS PRIOR TO REPORTING TO CANDELA. TWO REGULAR OPERATORS OF THE DEVICE HAVE BEEN IMPACTED. THE OFFICE MANAGER DOESN'T WORK HABITUALLY WITH THE LASER BUT REPORTED SHE EXPERIENCED THE SAME WHEN SHE COVERED FOR THE TWO OPERATORS WHEN THEY WERE AWAY ON HOLIDAYS. THE OFFICE MANAG

  Patient problems: Eye Irritation

  MAUDE report 15854922 ↗
• InjuryMar 28, 2018Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2018, THE (B)(6) ACCOUNT IN US REPORTED THAT PATIENT RESPONSE TO TREATMENT WITH BURN. WE TRIED TO REACH THIS FACILITY NUMEROUS TIMES TO OBTAIN MORE INFORMATION ON PATIENT CONDITION OR TYPE OF INJURY WITHOUT ANY SUCCESS. THEREFORE, DUE TO LACK OF ANY INFORMATION FROM THE FACILITY, WE ARE SUBMITTING THIS MDR AS A PRECAUTION.

  Patient problems: Injury

  MAUDE report 7379680 ↗