MAUDE Adverse Event Report: Acclaro Corporation UltraClear; Fractional Mid-IR Laser

Model Number	AS-WB-00055
Medical Device Problem Code	Misfocusing (1401)
Health Effect - Clinical Codes	Erythema (1840); Superficial (First Degree) Burn (2685)
Date of Event	08/12/2026
Type of Reportable Event	Serious Injury

• Brand Name: UltraClear
• Common Device Name: Fractional Mid-IR Laser
• Manufacturer (Section D): Acclaro Corporation; 333 george washington hwy; smithfield RI 02917
• Manufacturer (Section G): Acclaro Corporation; 333 george washington hwy; smithfield RI 02917
• Manufacturer Contact: david pluhar ; 333 george washington hwy; smithfield, RI 02917 ; +1(866)222-5276
• MDR Report Key: 50947757
• Report Number: 3021550489-2026-00014
• Device Sequence Number: 9534694
• Product Code: ONG
• UDI-Device Identifier: 00850039149016
• Combination Product (Y/N): N
• Initial Reporter State: RI
• Initial Reporter Country: US
• PMA/510(K) Number: K233803
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/30/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: AS-WB-00055
• Device Catalogue Number: AS-WB-00055
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/18/2026
• Initial Report FDA Received Date: 09/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/16/2023
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 69 YR
• Patient Sex: Female