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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
InitiatedRecall #ClassStatusReasonQuantityLink basis
2023-09-01Z-0324-2024Class IIOpen, ClassifiedIt has been found that potential unintended laser activation can occur without foot pedal depression.Distribution: Worldwide - US Nationwide distribution in the states of AK, AL, CA, CT, FL, KY, ME, MI, MO, MT, NC, OH, OR, PA, TN, TX, UT, VA, WA, WI and the country of Canada.39 unitscode info di
Regulatory clearances
  • 510(k)K151306Substantially equivalent (SESE) · 2015-09-23clearance 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
2017-04-18NAINo action indicatedConvergent Dental0
2017-04-18NAINo action indicatedConvergent Dental0
2014-09-08NAINo action indicatedConvergent Dental0
2014-09-08NAINo action indicatedConvergent Dental0
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