When medical devices are imported into a U.S. market, they must be approved by Food and Drug Administration (FDA) in advance. St.Shine intends to develop the market in U.S. through Optical Connection Inc.. The corporation submitted Section 510(k) premarket notification to FDA on March 21, 2002. After FDA review, the clearance letter was received on May 6, 2002, allowing us to begin marketing lenses in United States.

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