MAUDE Adverse Event Report: CYNOSURE LLC ELITE+

Catalog Number	105-7018-000
Medical Device Problem Code	Unexpected/Unintended Radiation Output (4028)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device history record confirms that the product passed and met all requirements before releasing.Cynosure field service engineer (fse) arrived at site and evaluated the device.Fse was not able to duplicate the reported issue.Fse created a hook and mounted it on the side panel to hold the foot pedal tube and prevent it from getting under the system.Fse concludes system is working within published specification.Based on the site's report of an unintended discharge of laser energy, this event is considered an accidental radiation occurrence (aro) and represents a device malfunction that is reportable under 21 cfr part 803 in accordance with u.S.Food and drug administration mdr requirements.
Event or Problem Description
Site reported elite+ was firing laser on its own without a foot pedal connected prior to starting treatment.No injuries occurred.

• Brand Name: ELITE+
• Common Device Name: ELITE+
• Manufacturer (Section D): CYNOSURE LLC; 5 carlisle road; westford MA 01886
• Manufacturer Contact: nirav desai ; 5 carlisle road; westford, MA 01886 ; 9783940763
• MDR Report Key: 25141965
• Report Number: 1222993-2026-00027
• Device Sequence Number: 9543391
• Product Code: GEX
• UDI-Device Identifier: 00841494100063
• UDI-Public: (01)00841494100063(11)190201
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K141425
• 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
• Type of Report: Initial
• Report Date (Section B): 05/11/2026

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: Other
• Device Catalogue Number: 105-7018-000
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/14/2026
• Initial Report FDA Received Date: 05/11/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/19/2019
• 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