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Adverse-event reports (MAUDE)

Read this first: MAUDE report counts cannot be used to compute incidence rates or compare device safety. Reporting is incomplete, duplicated, and spikes with publicity; there is no denominator of devices in use. The peer line shows reporting volume for the average device in the same FDA product code — a reporting baseline, not a risk measure.

No adverse-event reports are linked to this device.

Recall history

No recalls linked.

Regulatory clearances
  • 510(k)K171992Substantially equivalent (SESE) · 2017-09-26clearance family

Predicate lineage

Lineage each submission cites, walked transitively (indented = the cited device's own predicates). Extracted from public 510(k) summary text — heuristic, and includes reference devices mentioned alongside true predicates.

Manufacturer compliance record
DateTypeOutcomeFacilityCitations
2025-12-12NAINo action indicatedCynosure, LLC0
2025-12-12NAINo action indicatedCynosure, LLC0
2018-07-27VAIVoluntary action indicatedCynosure, LLC1
2018-07-27VAIVoluntary action indicatedCynosure, LLC1
2017-03-13NAINo action indicatedCynosure, LLC0
2017-03-13NAINo action indicatedCynosure, LLC0
2014-11-21VAIVoluntary action indicatedCynosure, LLC3
2014-11-21VAIVoluntary action indicatedCynosure, LLC3
2014-08-07VAIVoluntary action indicatedCynosure, Inc.2
2014-04-28VAIVoluntary action indicatedCynosure, LLC2
2014-04-28VAIVoluntary action indicatedCynosure, LLC2
2012-05-11VAIVoluntary action indicatedCynosure, Inc.2
2012-04-25VAIVoluntary action indicatedCynosure, LLC3
2012-04-25VAIVoluntary action indicatedCynosure, LLC3
2012-02-17VAIVoluntary action indicatedCynosure, LLC1
2012-02-17VAIVoluntary action indicatedCynosure, LLC1
2011-09-15NAINo action indicatedCynosure, LLC0
2011-09-15NAINo action indicatedCynosure, LLC0
2010-05-26VAIVoluntary action indicatedCynosure, Inc.2
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