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36C24720R0041 Sole Source Lumenis - Adulteration Letter for Service-Updated.pdf

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05/13/2019

Dear Customer, As a world leader in manufactured medical laser systems in the Aesthetic, Surgical, and Ophthalmic medical specialties, Lumenis strongly discourages the use of components, spare parts, replacement parts, or laser system supplies from sources other than Lumenis or Lumenis qualified sourcing. Lumenis does not design, test or receive regulatory market clearance or approval for our laser systems with any other manufacturer’s components, spare parts, replacement parts, or laser system supplies. In addition, Lumenis does not train or provide procedures or updates to independent service technicians nor does

Lumenis provide special tools and test fixtures required for repair or refurbishment activities except to

Lumenis employees.

Lumenis is aware that outside service providers and parts suppliers may offer their services at discounted prices. Based on our analysis of returned products, these outside services and parts have been found to be inferior in many instances in that they do not meet our stringent quality and workmanship standards, which may not be capable of restoring the devices to the original specifications, and may compromise patient or user safety. In examined units returned from customers where outside work has been performed, we have seen numerous instances of poor work quality, evidence of inadequate technical understanding to perform repairs, and the use of poor quality of parts and materials. In such instances, Lumenis cannot be confident that the product will perform to the high standards, if at all, that were established when the product was released and you have come to expect from a Lumenis product.

Please note that the Lumenis warranty applies exclusively to products manufactured by and for Lumenis and supplied by Lumenis. We believe that service provided by a Lumenis trained and backed representatives using Lumenis qualified parts is critical to the proper functioning and longevity of the device. As a result, please be aware that the use of any non-Lumenis products, components, parts, and/or services invalidates the warranty protection provided by Lumenis.

In summary, only those materials labeled as Lumenis qualified products are suitable for use with

Lumenis laser systems. Further, service may only be provided by Lumenis employees. You can obtain information about Lumenis qualified and approved materials and services by calling 877-586-3647, visiting the Lumenis website at http://www.lumenis.com, or by contacting your Lumenis Sales

Representative.

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