Excimer Lasers Manufactured for Export

Why FDA issued it

Note: The revision of this Import Alert (IA) dated 11/22/2022 updates the name of the alert, subtype to firm alert, reason for alert and guidance sections including agency contacts, charge code language, PAF, PAC. Changes to the import alert are bracketed by asterisks (***). ***These Excimer lasers laser systems are for the correction of refractive error by reshaping the surface of the cornea. The high-energy ultraviolet (UV) light is from pulsed gas (e.g., argon-fluoride) excimer laser system. The wavelength for argon-fluoride excimer lasers used for refractive surgery is 193 nm. The UV energy from the excimer laser disrupts the chemical bonds in the cornea without causing any thermal damage to surrounding tissue. These devices were exported under Section 801(e)(2) prior to approval of the PMA and then introduced or delivered for introduction into U.S. interstate commerce for commercial

Quoted from the “Reason for Alert” section of the FDA page for 86-09, mirrored 30 August 2026. The quotation is truncated at the length this copy carries.