CO2RE System for US, Packaged FG70412USRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 07290109952116), received between Nov 17, 2022 and Jul 6, 2023 — classified as 2 injuries.

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

• InjuryJul 6, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A PATIENT ADVOCATE REPORTED THAT A FEMALE PATIENT WAS TREATED WITH A CO2RE LASER AT A CLINIC IN NEW JERSEY ON (B)(6) 2021, ALLEGING THAT THE PATIENT SUSTAINED UNSPECIFIED INJURIES. NO PATIENT HISTORY, MEDICATIONS, NOR FITZPATRICK SKIN TYPE WAS PROVIDED. NO TREATMENT DETAILS / TREATMENT PARAMETERS WERE PROVIDED. NO INJURY DETAILS NOR MEDICAL INTERVENTION PROVIDED. DOCUMENTATION NOTES THAT THE DEVICE USED FOR THE TREATMENT WAS RENTED FROM A THIRD-PARTY ENTITY. THERE IS NO FURTHER INFORMATION AVAILABLE AT THIS TIME TO ASSESS. THE DOCUMENTATION RECEIVED INCLUDED AN AFFIDAVIT STATEMENT FROM A MEDICAL DOCTOR (MD) NOTING THAT "WITHIN A REASONABLE DEGREE OF MEDICAL PROBABILITY THAT THE PATIENT HAS SUSTAINED PERMANENT INJURY." THE MD DOES NOT STATE THE TYPE OF INJURY AND / OR ANY TREATMENT INTERVENTION REQUIRED, ONLY THAT THERE IS "PERMANENT INJURY," THEREFORE, CANDELA IS REPORTING THIS EVENT.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 17270789 ↗
• InjuryNov 17, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  WHILE PROVIDING CLINICAL TRAINING AT A CUSTOMER CLINIC IN CALIFORNIA, THE (B)(6) CLINICAL TRAINER WAS APPROACHED BY A PHYSICIAN WHO WAS NOT PARTICIPATING IN THE TRAINING BUT WANTED TO REVIEW AN ALLEGED REACTION FROM A TREATMENT WITH ANOTHER CANDELA DEVICE IN THE CLINIC. THE PHYSICIAN PRESENTED A PHOTO OF A PATIENT'S SKIN REACTION POST TREATMENT WITH A CORE DEVICE. THE IMAGE SHOWED A FEMALE WITH VISIBLE SCARRING OVER THE NECK AND CHEST AREA. NO PATIENT HISTORY OR TREATMENT PARAMETER DETAILS PROVIDED. THE IMAGE WAS REVIEWED WITH (B)(6) CLINICAL TEAM. BASED ON LIMITED INFORMATION AVAILABLE, IT APPEARS THAT THE SCARS WILL RESULT IN PERMANENT DAMAGE AND MAY REQUIRE SURGICAL INTERVENTION. ADDITIONAL INFORMATION HAS BEEN SOLICITED. NO FURTHER INFORMATION RECEIVED TO DATE. THE CASE WILL BE REASSESSED UPON RECEIPT OF NEW AND/OR RELEVANT INFORMATION.

  Patient problems: Scar Tissue

  MAUDE report 15811863 ↗