MAUDE Adverse Event Report: LUTRONIC CORPORATION CLARITY II

Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	Burn(s) (1757)
Date of Event	02/19/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A member of the cynosure lutronic clinical team made contact with the treatment site and determined that the treatment parameters used were slightly aggressive.The clarity ii quickstart guide (qsg) parameters for fluence are 12-16.Additionally, the qsg states that one pass is recommended during treatment.The patient was treated at 16j/cm2 which is within the recommended guidelines of the qsg, however, it was noted that the fluence was at the maximum and that the patient was treated with two (2) passes, which made the treatment parameters used aggressive.This may have contributed to the reported side effects.The patient was prescribed aquaphor, triamcinolone and silvadene as preventative and went to a plastic surgeon on their own for consultation.Images of the patients burn were sent to the cynosure lutronic medical director who stated that there was either areas that have loss of epidermis or loss of dermal tissue and that there was a possibility of scarring.It was recommended that the patient uses a gentle cleanser twice a day while lightly scrubbing the area to help debride all the slough, with a thin, clean wash cloth.Then apply aquaphor to non-full thickness affected areas and to the other areas silvadene.Monitor closely for infection.The medical directors recommendations were given to the treatment site and to reduce the probability of reoccurrence, retraining was dispatched to the treatment site.The event is reportable per fda medical device reporting title 21 cfr part 803 since a serious injury occurred.
Event or Problem Description
It was reported that a patients experienced elevated erythema and darkening with possible blisters on the arms following pigmentation treatment with a clarity ii device.

• Brand Name: CLARITY II
• Common Device Name: CLARITY II
• Manufacturer (Section D): LUTRONIC CORPORATION; lutronic center; 219 sowon-ro; deogyang-gu, goyang-si 10534 ; KS 10534
• Manufacturer (Section G): LUTRONIC CORPORATION; lutronic center; 219, sowon-ro; deogyang-gu, goyang-si 10534 ; KS 10534
• Manufacturer Contact: nirav desai ; 5 carlisle rd; westford, MA 01885
• MDR Report Key: 24688789
• Report Number: 3021199089-2026-00017
• Device Sequence Number: 9706070
• Product Code: GEX
• UDI-Device Identifier: 08809447653723
• UDI-Public: (01)08809447653723(11)250522
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K183566
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 03/25/2026

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
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/23/2026
• Initial Report FDA Received Date: 03/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/22/2025
• 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: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female