
Indigo Medical, Inc.
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INDIGO MEDICAL MODEL IDL 830 & MODEL IDL 830E LASER SYSTEMS FOR GENERAL GYNECOLOGICAL APPLICATIONS is an FDA 510(k)-cleared medical device (K963081) manufactured by Indigo Medical, 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 February 20, 1997. Regulation: 8.