RegWardenFDA facility compliance records
Facility

CYNOSURE, LLC

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

Activity by year

FDA actions on record by year2014: 1 recalls; 2017: 1 inspections; 2018: 1 inspections; 2025: 1 inspections1’14’15’161’171’18’19’20’21’22’23’241’25’26
  • Recalls (1)
  • Inspections (3)

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 IITerminated2014-10-09
    If the laser system is turned on and the user adjusts, installs or removes the XPL pulsed light handpiece, there is a potential risk of an electrical shock

FDA inspections (3)

  • NAI2025-12-12
    No Action Indicated · Compliance: Devices; Postmarket Assurance: Devices; Radiation Control and Health Safety Act
  • NAI2018-07-27
    No Action Indicated · Compliance: Devices; Radiation Control and Health Safety Act · citations posted
  • NAI2017-03-13
    No Action Indicated · Radiation Control and Health Safety Act

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. “CYNOSURE, LLC (FEI 1000120578) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/1000120578-cynosure-llc/

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