# Regulatory Compliance

Pre-Sure® physical replicas are intended for adjunctive use along with other diagnostic tools and expert clinical judgment for diagnosis, patient management, and/or treatment selection of genitourinary applications.

Pre-Sure® physical replicas are created in soft silicone materials that can be cut, sutured, and in some cases even bleed. These unique capabilities may provide new opportunities for pre-surgical planning and rehearsal.

Please refer to the [Pre-Sure® Instructions for Use manual](https://laz-3d.cdn.prismic.io/laz-3d/cc565237-8936-42bd-b4c1-184a54865ffa_Pre-Sure+Lazarus+3D+IFU+Version+10.0.pdf?&dl) for additional instructions on Pre-Sure®. You can find the FDA clearance document for Pre-Sure® [here](https://www.accessdata.fda.gov/cdrh_docs/pdf20/K201835.pdf).

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Pre-Sure® is intended for use in diagnosis, patient management, and/or treatment selection. Pre-Sure is covered by billing (CPT) codes issued by the American Medical Association.

Federal law restricts Pre-Sure to sale, distribution and use by, or on the order of, a physician.