FDA Product Code OAN: Orthosis, Cranial, Laser Scan
Laser-scanned cranial orthoses provide precise, non-invasive treatment for positional plagiocephaly. FDA product code OAN covers cranial orthoses fabricated from digital laser scans of the infant's head.
These custom-fitted helmets use controlled pressure and free space zones to redirect skull growth and correct asymmetric head shape in infants with deformational plagiocephaly and brachycephaly during the period of active skull growth.
OAN devices are Class II medical devices, regulated under 21 CFR 882.5970 and reviewed by the FDA Neurology panel.
Leading manufacturers include Orthomerica Products, Inc..
FDA 510(k) Cleared Orthosis, Cranial, Laser Scan Devices (Product Code OAN)
How to use this database
This page lists all FDA 510(k) submissions for Orthosis, Cranial, Laser Scan devices (product code OAN). Click any device to view full submission details, including the decision date, manufacturer information, predicate device, and a link to the official FDA record.
These devices fall under the Neurology FDA review panel. Browse all Neurology devices →