MAUDE Adverse Event Report: CYNOSURE LLC PICOSURE PRO

Catalog Number	105-7051-000
Medical Device Problem Code	Unexpected/Unintended Radiation Output (4028)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/13/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device history record confirms that the product met all release requirements prior to distribution.The site declined evaluation of the device by a cynosure-trained field service engineer, as the unintended radiation output was determined to be the result of user error.On (b)(6) 2026, a member of the cynosure clinical team followed up with the treatment provider and confirmed that no patient injury occurred.The clinical team also reviewed proper device use guidelines and emphasized that the laser caster wheels should not be rolled over the footswitch cable to prevent recurrence.Based on the site's report of unintended discharge of laser energy, this event is considered an accidental radiation occurrence (aro) and represents a reportable device malfunction under 21 cfr part 803 in accordance with u.S.Fda medical device reporting requirements.
Event or Problem Description
It was reported that a picosure pro device discharged laser energy unintentionally after the footswitch cable became trapped beneath a laser caster wheel.No patient injury was reported.

• Brand Name: PICOSURE PRO
• Common Device Name: PICOSURE PRO
• Manufacturer (Section D): CYNOSURE LLC; 5 carlisle road; westford MA 01886
• Manufacturer Contact: nirav desai ; 5 carlisle road; westford, MA 01886
• MDR Report Key: 25487085
• Report Number: 1222993-2026-00055
• Device Sequence Number: 15944164
• Product Code: GEX
• UDI-Device Identifier: 00841494100537
• UDI-Public: (01)00841494100537(11)240627
• Combination Product (Y/N): N
• Initial Reporter Country: KN
• PMA/510(K) Number: K210226
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/12/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 105-7051-000
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/13/2026
• Initial Report FDA Received Date: 06/12/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/12/2024
• 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
• Patient Sex: Unknown