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All Fotona medical lasers are CE marked and cleared for sale in the EU. For countries where specific national approvals or clearances are required (for example by the FDA in the United States), some of the products and/or applications may not have been cleared yet. Similarly, local patents may limit usage for certain technologies and applications. Please check with Fotona, your local Fotona distributor or your national regulatory body to find out whether a specific product or application is available for sale and use in your country.