RegWardenFDA facility compliance records
Facility

LUMENIS BE INC.

3 recall(s) on record — most severe on record: Class I.

Activity by year

FDA actions on record by year2013: 1 recalls; 2014: 1 recalls; 2016: 1 inspections; 2018: 1 inspections; 2021: 1 recalls1’131’14’151’16’171’18’19’201’21’22’23’24’25’26
  • Recalls (3)
  • Inspections (2)

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 ITerminated2021-10-14
    Ultrasound gels and lotions manufactured by Eco-Med Pharmaceutical, Inc. may contain bacterial contamination. On August 18, 2021, FDA published a Letter to Health Care Providers to further address this issue: https://www.fda.gov/medical-devices/letters-health-care-providers/stop-…
  • Class IITerminated2014-08-15
    Lumenis initiated a field-correction for the Array Laser Link", GA-0006700 (SN XXYYZZ) because the system may project an erroneous pattern display on the retina, which is different than the desired pattern.
  • Class IITerminated2013-08-19
    Lumenis has initiated a recall on certain models of Vision One System due to a potential for unintended laser exposure to the user.

FDA inspections (2)

  • NAI2018-10-30
    No Action Indicated · Compliance: Devices; Postmarket Assurance: Devices; Radiation Control and Health Safety Act
  • VAI2016-09-13
    Voluntary Action Indicated · Compliance: Devices; Postmarket Assurance: Devices; 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. “LUMENIS BE INC. (FEI 1720381) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/1720381-lumenis-be-inc/

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