RegWardenFDA facility compliance records
Facility

Candela Corporation

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

Activity by year

FDA actions on record by year2013: 1 recalls; 2019: 1 recalls; 2023: 1 inspections1’13’14’15’16’17’181’19’20’21’221’23’24’25’26
  • Recalls (2)
  • Inspections (1)

Devices registered here (1)

  • Powered Laser Surgical Instrument
    Product code GEX (opens in a new tab) · Class II · General, Plastic Surgery · 21 CFR 878.4810

Recalls & enforcement

  • Class IITerminated2019-09-10
    The canister neck bushing may become loose and separate from the body of the canister during use. The issue occurs only when the canisters are used in Candela legacy devices that utilize screw-in or threaded interface type DCD modules
  • Class IITerminated2013-11-06
    Unintended single pulse maybe emitted to handpiece prior to pressing of trigger or footswitch and cause injury.

FDA inspections (1)

  • VAI2023-01-24
    Voluntary Action Indicated · Radiation Control and Health Safety Act · citations posted

Source: U.S. FDA Inspections Dashboard (opens in a new tab) (device inspection classifications, 2016–present). Data as of 2026-10-06. The dashboard profile can take several seconds to load.

Related

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this facility record at FDA → (opens in a new tab)

Cite this record

RegWarden. “Candela Corporation (FEI 3016496662) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3016496662-candela-corporation/

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