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CLEAR+BRILLIANT TOUCH CBT-CONSOLERecalls & reported problems

Solta Medical · CLEAR+BRILLIANT CONSOLE · Class 2

Adverse event reports
2
Deaths reported
0
Injuries reported
2
Recalls naming it
0

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00816995027300), received between Jan 30, 2024 and Nov 12, 2024 — 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. How this data works · Data updated Oct 13, 2026.

Reports received per month

Nov 2023: 0 reportsDec 2023: 0 reportsJan 2024: 1 reportsFeb 2024: 0 reportsMar 2024: 0 reportsApr 2024: 0 reportsMay 2024: 0 reportsJun 2024: 0 reportsJul 2024: 0 reportsAug 2024: 0 reportsSep 2024: 0 reportsOct 2024: 0 reportsNov 2024: 1 reportsDec 2024: 0 reportsJan 2025: 0 reportsFeb 2025: 0 reportsMar 2025: 0 reportsApr 2025: 0 reportsMay 2025: 0 reportsJun 2025: 0 reportsJul 2025: 0 reportsAug 2025: 0 reportsSep 2025: 0 reportsOct 2025: 0 reportsNov 2025: 0 reportsDec 2025: 0 reportsJan 2026: 0 reportsFeb 2026: 0 reportsMar 2026: 0 reportsApr 2026: 0 reportsMay 2026: 0 reportsJun 2026: 0 reportsJul 2026: 0 reportsAug 2026: 0 reportsSep 2026: 0 reportsOct 2026: 0 reports2024202520261
Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

  • Adverse Event Without Identified Device or Use Problem2

Patient problems

  • Erythema2
  • Hyperpigmentation2
  • Burn(s)1
  • Pain1
  • Skin Discoloration1

Recent adverse event reports

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

  • InjuryNov 12, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    A PATIENT REPORTED ON SOCIAL MEDIA THAT THEY HAD RECEIVED A CLEAR+BRILLIANT TOUCH TREATMENT ON THEIR FACE APPROXIMATELY 3 1/2 YEARS PRIOR TO THIS REPORT. SHE REPORTED HAVING TANNED SKIN AND BROWN PATCHES POST TREATMENT. THE PATIENT WAS CONTACTED FOR FURTHER INFORMATION AND REPORTED THAT THE C+B TREATMENT LEFT HER SKIN RED WITH PERMANENT TAN AND BROWN PATCHES ON HER FACE. SHE ALSO STATED THAT SHE FOLLOWED UP WITH THE ESTHETICIAN THAT PERFORMED THE PROCEDURE AND WAS TOLD THAT IT WAS NORMAL. SHE WENT ON TO SAY SHE NOW HAS TO WEAR A DIFFERENT COLOR SHADE OF FOUNDATION TO COVER THE PATCHES, AND SINCE THE PROCEDURE, HAS TRIED DIFFERENT LIGHTENING METHODS TO GET HER SKIN BACK TO THE CORRECT COLOR. THE USER FACILITY WAS THEN CONTACTED AND PROVIDED ADDITIONAL DETAILS OF THE TREATMENT. IT WAS NOTED THE USER FACILITY IS UNSURE, SINCE THEIR OFFICE WAS NEVER CONTACTED REGARDING ANY PAIN, ISSUES POST CLEAR AND BRILLIANT. THEY ALSO NOTED THAT THE LAST CONTACT MADE REGARDING THIS WAS 12 DAYS POST TREATMENT WHICH REPORTED, "PATIENT DOING WELL POST C&B, MENTIONED PIGMENTATION HAS TURNED DARKER AND HAS THE ROUGH TEXTURE TO HER SKIN THAT WE DISCUSSED KEEPING SPF AND MOISTURIZER ON HER SKIN. PATIENT WI

    Patient problems: Erythema; Hyperpigmentation; Pain; Skin Discoloration

    MAUDE report 20669423 ↗
  • InjuryJan 30, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    A USER FACILITY REPORTED REBOUND HYPERPIGMENTATION 5 HOURS AFTER A CLEAR + BRILLIANT TOUCH TREATMENT TO THE FACE. THE PATIENT COMPLAINED TO THE PROVIDER THAT SHE HAD A LOT OF REDNESS AND SENSITIVITY. THE PATIENT INDICATED 6 DAYS POST TREATMENT THAT BROWN SPOTS ON HER CHEEKS WERE DARKER THAN PRIOR TO THE TREATMENT. ABOUT 3 WEEKS POST TREATMENT, THE PATIENT REPORTED TO THE PROVIDER THAT HER SKIN WAS BURNED AND THAT THE SKIN PIGMENTATION REMAINS DARKER THAN PRIOR TO THE TREATMENT. CURRENTLY THE PATIENT PRESENTS WITH REBOUND HYPERPIGMENTATION. THE EXACT LOCATION OF THE INJURY IS REPORTED TO BE ON BOTH CHEEKS WITH IT BEING MORE NOTICEABLE TO THE LEFT CHEEK. NO SECONDARY TREATMENT WAS PROVIDED BUT THE PATIENT IS USING THE SAME PRODUCTS AS BEFORE THE TREATMENT, WHICH INCLUDES: CERAPHIL DAILY FACIAL CLEANSOR AND CERA-V MOISTURIZING LOTION OIL FREE. IT IS UNKNOWN IF THERE WILL BE ANY PERMANENT DAMAGE OR SCARRING. NO OTHER TREATMENTS (BESIDES C+B TOUCH) WERE BEING PERFORMED IN THE SAME AREA WHERE SYMPTOMS WERE REPORTED. THE PATIENT HAS NOT UNDERGONE ANY OTHER TREATMENTS IN THE SAME SYMPTOM AREA WITHIN THE PAST 30 DAYS. HOWEVER, THE PATIENT HAD A SAMPLING OF FRAXEL ON THE CHIN AREA ONLY WHICH

    Patient problems: Burn(s); Erythema; Hyperpigmentation

    MAUDE report 18608067 ↗

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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.