LaseMD Ultra LaseMD Ultra U120VRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 08809447653044), received between Jul 16, 2025 and Jul 16, 2025 — 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 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.

• InjuryJul 16, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT EXPERIENCED PRONOUNCED EDEMA POST SOFT TISSUE COAGULATION TREATMENT WITH A LASEMD ULTRA DEVICE.

  Patient problems: Hypersensitivity/Allergic reaction

  MAUDE report 22523716 ↗
• InjuryJul 16, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT EXPERIENCED PRONOUNCED EDEMA POST SOFT TISSUE COAGULATION TREATMENT WITH A LASEMD ULTRA DEVICE. CYNOSURE LUTRONIC CLINICAL TEAM COLLECTED ADDITIONAL INFORMATION AND DETERMINED THE CASE TO BE INCONCLUSIVE. SITE PHYSICIAN SUSPECTS THE PATIENT HAD AN ALLERGIC TYPE RESPONSE. TREATMENT PARAMETERS USED WERE WITHIN THE RECOMMENDED RANGE. NUMBING CREAM WAS APPLIED PRIOR TO TREATMENT. POST TREATMENT BE FACIAL MASK, VITAMIN C AMPOULE, PREDNISONE ATAR AND HEALITE TREATMENT WERE APPLIED AS PREVENTATIVE. PATIENT REPORTED THE FOLLOWING DAY AFTER TREATMENT THAT HER FACE WAS MORE SWOLLEN AND SHE WAS UNABLE TO SEE. SITE CONFIRMED PATIENT HAD SEVERE PERIORBITAL EDEMA AND CLEAR YELLOW DRAINAGE. THE CASE WAS DISCUSSED WITH AN INFECTIOUS DISEASE DOCTOR, WHO RECOMMENDED THAT THE PATIENT RECEIVE DIRECT ADMISSION FOR IV ANTIBIOTICS AND IV STEROIDS. THE PATIENT RECEIVED V ANCEF, CLINDAMYCIN AND SOLUMEDROL. LABS SHOWED LEUKOCYTOSIS 13 > 15, ELEVATED LACTIC ACID, 3.3. FOLLOWING THE IV TREATMENT IT WAS REPORTED THAT THESE NUMBERS TRENDED DOWN AS EXPECTED. THE PATIENT WAS DISCHARGED TWO (2) DAYS LATER AND IT WAS REPORTED THAT THEY RECOVERED WELL AND CAN SEE SIGNIFICANT IMPROVEMEN

  Patient problems: Hypersensitivity/Allergic reaction

  MAUDE report 22521283 ↗