RegWardenFDA facility compliance records
Company

Cutera, Inc.

1 recall(s) on record — most severe on record: Class II.

Recalls by year

FDA actions on record by year2013: 1 recalls1’13’14’15’16’17’18’19’20’21’22’23’24’25’26
  • Recalls (1)

Registered facilities (1)

Recalls & enforcement

  • Class IITerminated2013-10-16
    Cutera received two adverse events associated with the edge of the electrode, when it was pressed against neck skin over the thyroid cartilage and due to the absence of adequate underlying conductive tissue, increased skin heating occurred. Both patients developed linear welts an…

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. We restate the public record only — measured facts, never risk verdicts.

Cite this record

RegWarden. “Cutera, Inc. — FDA compliance profile.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/company/oo-9038697-cutera-inc/

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