RegWardenFDA facility compliance records
Facility

A.R.C. LASER GMBH

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

Activity by year

FDA actions on record by year2017: 1 recalls; 2023: 1 inspections120172018201920202021202212023202420252026
  • Recalls (1)
  • 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 IITerminated2017-07-24
    Failure to comply with performance standard requirements (21 CFR 1040.10(f))when operated in the user accessible auto and music modes of operation

FDA inspections (1)

  • VAI2023-09-21
    Voluntary Action Indicated · Compliance: Devices; Postmarket Assurance: Devices · 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. “A.R.C. LASER GMBH (FEI 3006617841) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3006617841-a-r-c-laser-gmbh/

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