
Huvitz Co., Ltd.
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SLIT LAMP, MODELS HS-5000, HS-5500 AND HS-7500 is an FDA 510(k)-cleared medical device (K093639) manufactured by Huvitz Co., 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 December 2, 2009. Regulation: 8.