Fraxel re:store DUAL Laser System MC-SYS-SR1500-D-USRecalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00816995020233), received between Jun 11, 2024 and Apr 7, 2026 — classified as 6 injuries.

The most frequently reported specific device problem is “Failure to Align” (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 18, 2026.

Most reported problems

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryApr 7, 2026Energy Output Problem

  A USER FACILITY REPORTED SWELLING, EXTENSIVE ERYTHEMA, OOZING/EXUDATIVE DRAINAGE FROM THE SKIN, AND ODOR FOLLOWING A FRAXEL FACIAL TREATMENT. DURING THE PROCEDURE, THE TREATING PHYSICIAN NOTED CONCERN THAT THE SYSTEM MAY HAVE BEEN DELIVERING EXCESSIVE ENERGY. THE SYMPTOMS WERE FIRST REPORTED TO THE USER FACILITY BY THE PATIENT APPROXIMATELY TWO DAYS POST-TREATMENT. SECONDARY INTERVENTIONS CONSISTED OF AN ALASTIN REGIMEN (CLEANSER, NECTAR SERUM, AND MOISTURIZER) FOR TWO DAYS POST-PROCEDURE. ON DAY 3, THE ALASTIN PRODUCTS WERE DISCONTINUED, AND THE PATIENT INITIATED AQUAPHOR AND DILUTE VINEGAR SOAKS. ORAL ANTIBIOTICS (CLINDAMYCIN 300 MG TID) AND ANTIVIRAL THERAPY (VALACYCLOVIR 1000 MG BID) WERE PRESCRIBED. POST-INFLAMMATORY HYPERPIGMENTATION (PIH) PROPHYLAXIS WAS INITIATED WITH TRANEXAMIC ACID 650 MG DAILY. HYDROCORTISONE 1% TOPICAL BID WAS ALSO INITIATED FOR ERYTHEMA. AT APPROXIMATELY ELEVEN DAYS POST-TREATMENT, THE PATIENT¿S CONDITION WAS REPORTED AS HEALING WELL, WITH CONTINUED ERYTHEMA PRESENT. EXUDATIVE DRAINAGE AND SWELLING HAD IMPROVED. PERMANENT DAMAGE AND SCARRING WERE CONSIDERED UNLIKELY; HOWEVER, IT WAS NOTED TO BE TOO EARLY TO DETERMINE DEFINITIVELY. FIVE PHOTOGRAPHS TAKE

  Patient problems: Abrasion; Erythema; Localized Skin Lesion; Purulent Discharge; Swelling/ Edema; Wound Odor

  MAUDE report 24811130 ↗
• InjuryDec 23, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  APPROXIMATELY TEN MONTHS POST THE INITIAL FRAXEL TREATMENT, THE PATIENT PRESENTED FOR CONSULTATION REGARDING ABDOMINOPLASTY AND EXPRESSED CONCERNS ABOUT ABDOMINAL SKIN PIGMENTATION AND EXCESSIVE SCARRING FOLLOWING PRIOR LASER HAIR REMOVAL TREATMENTS AT ANOTHER SPA. THE PROVIDER EXPLAINED THAT PIGMENTATION CHANGES ARE MORE LIKELY RELATED TO LASER TREATMENT, SKIN TYPE, AND PREVIOUS INFLAMMATION, RATHER THAN SURGICAL INTERVENTION, AND ADVISED AGAINST FURTHER LASER TREATMENTS IN THE AREA. SURGICAL RISKS, INCLUDING HYPERTROPHIC SCARRING, WOUND HEALING COMPLICATIONS, UMBILICAL NECROSIS, SEROMA, AND NEED FOR VERTICAL INCISION, WERE DISCUSSED IN DETAIL. THE PATIENT WAS COUNSELED THAT SCAR APPEARANCE CANNOT BE GUARANTEED AND THAT INTRAOPERATIVE DECISIONS MAY ALTER SURGICAL PLANNING. THE PATIENT REPORTED UNDERGOING SUBSEQUENT CORRECTIVE PROCEDURES, WHICH WERE CHARACTERIZED BY THE REPORTER AS PERFORMED WITHOUT ADEQUATE INFORMED CONSENT, RESULTING IN ADDITIONAL PERMANENT DEFORMITIES. THE REPORTER ALLEGES MEDICAL BATTERY AND STATES THAT THESE CORRECTIVE INTERVENTIONS WORSENED THEIR CONDITION. MEDICAL RECORDS, PATIENT IMAGES, AND LEGAL DOCUMENTATION WERE RECEIVED AND REVIEWED BY SOLTA. THE MEDIC

  Patient problems: Hyperpigmentation; Physical Asymmetry; Skin Inflammation/ Irritation; Tissue Breakdown

  MAUDE report 23884160 ↗
• InjuryMar 27, 2025Failure to Align; Failure to Align

  ADDITIONAL INFORMATION WAS RECEIVED AND REPORTED THAT THERE IS NO SCARRING TO THE PATIENT. SINCE NO TREATMENT BEYOND THE STANDARD OF CARE WAS REPORTED AND THE EVENT WAS RECOVERED WITH NO SCAR, THE CASE WAS DOWNGRADED AS NOT SERIOUS PER THE MEDICAL REVIEWER. THIS EVENT NO LONGER MEETS REPORTABILITY REQUIREMENTS.

  Patient problems: Blister; Erythema

  MAUDE report 21710851 ↗
• InjuryMar 27, 2025Failure to Align; Failure to Align

  UPDATED INFORMATION INCLUDES CONFIRMATION OF NO PATIENT SCARRING. HOWEVER, THE CASE REMAINS ASSESSED AS SERIOUS DUE TO THE EXTENT OF TREATMENT THAT INCLUDED ANTIBIOTICS, CORTICOSTEROIDS AND SECONDARY LASER THERAPY.

  Patient problems: Blister; Erythema; Swelling/ Edema

  MAUDE report 21710392 ↗
• InjuryJun 11, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A USER FACILITY REPORTED HYPERPIGMENTATION AND REDNESS TO THE FACE IMMEDIATELY AFTER A DEMONSTRATION FRAXEL TREATMENT. IT WAS REPORTED THAT NEW PIGMENT BECAME NOTICEABLE HOURS TO DAYS AFTER THE TREATMENT. AT THE TIME OF THE INITIAL REPORT, THE PATIENT'S CURRENT STATUS WAS REPORTED TO BE WITH PIGMENTATION, POTENTIAL MELASMA, REDNESS, AND UNEVEN STRIPES. AVAILABLE PICTURES WERE ASSESSED BY THE MEDICAL REVIEWER, AND IT WAS DETERMINED THAT HYPERPIGMENTED AREAS ARE VISIBLE ON THE PATIENT'S CHEEKS AND FOREHEAD. IT IS UNKNOWN IF THERE WILL BE ANY PERMANENT DAMAGE OR SCARRING. NO OTHER TREATMENTS (BESIDES THE ONE REPORTED) WERE BEING PERFORMED IN THE SAME AREA WHERE SYMPTOMS WERE REPORTED, NOR HAS THE PATIENT UNDERGONE ANY OTHER TREATMENTS IN THE SAME SYMPTOM AREA WITHIN THE PAST 90 DAYS. THE PATIENT HAS PREVIOUSLY RECEIVED MULTIPLE FRAXEL TREATMENTS, INJECTABLES, AND INTENSED PULSE LIGHT THROUGHOUT THE YEARS AND HAS UNDERGONE TWO MORPHEUS TREATMENTS. PRIOR TO THE TREATMENT, THE PATIENT USED MOISTURIZER AND SUNSCREEN AND DURING HEALING, SKIN NECTAR, HYDRACELL, AND SUNSCREEN WERE USED. IT IS BELIEVED THAT THE PATIENT "NEVER" HAD SUN EXPOSURE DURING HEALING AND POST HEALING AND LIKELY HAS A

  Patient problems: Erythema; Hyperpigmentation; Skin Discoloration

  MAUDE report 19514827 ↗
• InjuryJun 11, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A USER FACILITY REPORTED PATIENT HYPERPIGMENTATION AND MELASMA FOLLOWING A DEMONSTRATION FRAXEL TREATMENT. THE TREATMENT WAS PERFORMED ON AN EMPLOYEE OF THE USER FACILITY, WITH A SOLTA EMPLOYEE OBSERVING THE TREATMENT. NOTHING ATYPICAL WAS NOTED DURING THE TREATMENT. A BURN PAPER TEST WAS PERFORMED BEFORE THE TREATMENT WITH THE SAME TREATMENT SETTINGS (10MJ, 7 TREATMENT SETTING) AND SHOWED PROPER COVERAGE. FOUR PATIENT PHOTOS WERE ASSESSED BY THE SOLTA MEDICAL REVIEWER. IT IS NOT CLEAR AS TO THE TIMING OR SEQUENCE OF THE PHOTOS. THE MEDICAL REVIEWER NOTED THAT THE PATIENT¿S FACE IS ERYTHEMATOUS, WITH MINOR HYPERPIGMENTATION VISIBLE IN SOME AREAS. THOUGH REQUESTED, NO ADDITIONAL INFORMATION HAS BEEN PROVIDED. IT WAS REPORTED THAT THE PATIENT IS NO LONGER AN EMPLOYEE OF THE USER FACILITY AND IS NOT BEING SEEN AT THE CLINIC FOR FOLLOW-UP.

  Patient problems: Erythema; Hyperpigmentation; Skin Discoloration

  MAUDE report 19514198 ↗