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. and Cranial Technologies, Inc..
FDA 510(k) Cleared Orthosis, Cranial, Laser Scan Devices (Product Code OAN)
About Product Code OAN - Regulatory Context
510(k) Submission Activity
23 total 510(k) submissions under product code OAN since 2001, with 23 receiving FDA clearance (average review time: 101 days).
Submission volume has remained relatively stable over the observed period, with 1 submissions in the last 24 months.
FDA Review Time
Recent submissions under OAN have taken an average of 76 days to reach a decision - down from 103 days historically, suggesting improved FDA processing for this classification.
OAN devices are reviewed by the Neurology panel. Browse all Neurology devices →