MAUDE Adverse Event Report: ACCLARO ULTRACLEAR; FRACTIONAL MID-IR LASER

Model Number	AS-WB-00055
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Skin Inflammation/ Irritation (4545)
Date of Event	04/13/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2026 the patient was treated with the ultraclear device using clear glide mode on the forearms.Clear glide mode delivers laser energy in a randomized pattern of rings.The settings used were 25% coverage and 20um depth.She experienced redness, inflammation, and irritation in the pattern of the treatment.Photographic evidence provided clearly showed the treatment pattern in the irritation on the forearms.The irritation persisted on the inner part of the forearms longer than other areas.The treating physician performed follow up treatments to mitigate the irritation.She was treated with glacial glide, a dermal cooling device, lidex cream (0.05% floucinonide), and v-beam, a 595nm laser.The treatments were effective and the irritation faded but was still visible on (b)(6) 2026.The patient was not on any photosensitizing treatments and had received erbium laser treatment on the face before with no issues.The patient defines herself as having sensitive skin according to the treating physician.Acclaro clinical reviewed the provided information and photographs.In the images dated (b)(6) 2026 and (b)(6) 2026, diffuse pinpoint red-brown macules were observed involving the bilateral lower arms, with findings appearing more prominent on the volar forearms.The distribution appeared non-uniform and speckled, with some regions demonstrating petechial-like features.No visible blistering, erosions, ulceration, drainage, crusting, or other overt signs of infection were noted in the provided photographs.The volar forearms demonstrated comparatively greater visibility of the observed findings relative to the dorsal forearms.The photographs provided date (b)(6) 2026 show that while signs of the irritation were still slightly visible the patient had largely healed.No permanent damage was reported or evident in photographs provided.Suspected cause for this adverse event is the patients self reported skin sensitivity.At the time of reporting the treating physician had provided no final conclusion on the patients condition.

• Brand Name: ULTRACLEAR
• Common Device Name: FRACTIONAL MID-IR LASER
• Manufacturer (Section D): ACCLARO; 333 george washington highway; smithfield RI 02917
• Manufacturer (Section G): ACCLARO; 333 george washington highway; smithfield RI 02917
• Manufacturer Contact: david pluhar ; 333 george washington highway; smithfield
• MDR Report Key: 25484839
• Report Number: 3021550489-2026-00006
• Device Sequence Number: 18575746
• Product Code: ONG
• UDI-Device Identifier: 00850039149429
• UDI-Public: (01)00850039149429(11)250613
• Combination Product (Y/N): N
• Initial Reporter State: DC
• Initial Reporter Country: US
• PMA/510(K) Number: K233803
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Nurse Practitioner
• Type of Report: Initial
• Report Date (Section B): 06/11/2026

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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/12/2026
• Initial Report FDA Received Date: 06/12/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/13/2025
• 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: 55 YR
• Patient Sex: Female
• Patient Race: White