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Igel Vision Care Pte , Ltd.
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IGEL 55 TORIC (METHAFILCON A) SOFT (HYDROPHILIC) CONTACT LENS FOR DAILY WEAR is an FDA 510(k)-cleared medical device (K021907) manufactured by Igel Vision Care Pte , Ltd.. This device is classified under the Ophthalmic specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on September 3, 2002. Regulation: 8.