MAUDE Adverse Event Report: CYNOSURE LLC APOGEE+

Catalog Number	105-7018-001
Medical Device Problem Code	Unexpected/Unintended Radiation Output (4028)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/22/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Cynosure clinical reached out to site for additional information.Cynosure clinical confirmed no injuries had occurred.Cynosure field service engineer (fse) arrived on site to evaluate the device.Fse confirmed the incident was caused by the foot switch cable being stepped on.The device history record was also reviewed and confirmed passing and meeting all requirements prior to release.Due to the site reporting an unintended discharge of laser energy, this event is an aro (accidental radiation occurrence) and therefore reportable.
Event or Problem Description
Site reported apogee+ laser shot out without operator pressing the foot pedal.

• Brand Name: APOGEE+
• Common Device Name: APOGEE+
• 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: 22814775
• Report Number: 1222993-2025-00026
• Device Sequence Number: 8756669
• Product Code: GEX
• UDI-Device Identifier: 00841494100070
• UDI-Public: (01)00841494100070(11)230928
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K034030
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 08/15/2025

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: Other
• Device Catalogue Number: 105-7018-001
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/22/2025
• Initial Report FDA Received Date: 08/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/20/2023
• 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: Other
• Patient Sex: Unknown