
Ellman Int'L, Inc.
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NON-ABLATIVE WRINKLE TREATENT HANDPIECE MODLE PELLEVE' is an FDA 510(k)-cleared medical device (K101967) manufactured by Ellman Int'L, 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 August 11, 2010. Regulation: 8.