
Mehl/Biophile Intl., Inc.
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IMPROVEMENTS TO THE MEHL RUBY LASER is an FDA 510(k)-cleared medical device (K971814) manufactured by Mehl/Biophile Intl., Inc.. This device is classified under the General, Plastic Surgery specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on July 31, 1997. Regulation: 8.