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)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No injuries were reported.Cynosure field service engineer (fse) arrived at the site and inspected the unit.Upon inspection, fse replaced the foot pedal to fix the issue reported by customer site.Due to site reporting an unintended discharge of laser energy, this event is an aro (accidental radiation occurrence) and therefore reportable.
Event or Problem Description
It was reported that when the operator takes their foot off the pedal, the laser device will still fire.

• 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: 23888275
• Report Number: 1222993-2025-00061
• Device Sequence Number: 15865547
• Product Code: GEX
• UDI-Device Identifier: 00841494100070
• UDI-Public: (01)00841494100070(11)250627
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 12/24/2025

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: 105-7018-001
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/28/2025
• Initial Report FDA Received Date: 12/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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