SRA applicator FG70621Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 07290109950891), received between Dec 22, 2021 and Dec 22, 2021 — classified as 1 injury.

The most frequently reported specific device problem is “Calibration Problem” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryDec 22, 2021Calibration Problem; Insufficient Device Problem Information; Calibration Problem; Insufficient Device Problem Information

  A CUSTOMER REPORTED THAT A (B)(6) FEMALE PATIENT HAD A FULL FACE "FOTOFACIAL" TREATMENT USING THE ELOSPLUS SRA HANDPIECE ON (B)(6) 2021. THE CUSTOMER ALSO REPORTED THAT THE PATIENT HAD NO PRIOR SUN EXPOSURE. PRIOR HISTORY OF AESTHETIC TREATMENT INCLUDES NEUROMODULATORS AND A PRIOR "FOTOFACIAL." A TEST SPOT WAS PERFORMED TO THE RIGHT LOWER FACE WITH A TISSUE RESPONSE OF ERYTHEMA NOTED. CUSTOMER REPORTED USING MULTIPLE TREATMENT SETTINGS THROUGHOUT THE PROCEDURE, ADJUSTING SETTINGS BASED UPON OBSERVATION OF SKIN REACTION. "DURING TREATMENT, MILD TO MODERATE ERYTHEMA WAS APPARENT IN STRIPED PATTERN." CUSTOMER REPORTED AN IMMEDIATE POST-TREATMENT REACTION OF "LINEAR ERYTHEMA PATTERNS, GRAYISH HUE TO SKIN." CUSTOMER NOTED, "WITHIN 18 HOURS AFTER TREATMENT, PATIENT CALLED CLINIC WITH COMPLAINTS OF BLISTERS APPROXIMATELY ONE (1) INCH IN LENGTH AND CIRCULAR BLISTERS ALONG TREATMENT PATTERNS." THE PATIENT WAS PROVIDED WITH AN IMMEDIATE IN-CLINIC ASSESSMENT. WOUND CARE, DEBRIDEMENT, AND TOPICAL BACITRACIN OINTMENT WERE PROVIDED. NO PRESCRIPTION MEDICATIONS WERE PRESCRIBED. REPORTED BLISTERS, MICRO CRUSTING, AND STRIPING WERE RESOLVED WHEN THE PATIENT WAS SEEN TWO MONTHS POST TREATMENT. CUSTO

  Patient problems: Scar Tissue; Skin Inflammation/ Irritation

  MAUDE report 13061062 ↗