OAN

Orthosis, Cranial, Laser Scan

Product code

OAN

Device name

Orthosis, Cranial, Laser Scan

Device class

Class 2

21 CFR

21 CFR 882.5970

Medical specialty

Neurology

Marketing pathway

510(K)

510(k) clearances (last 3 years)

2

Summaries archived here

2 (direct download)

510(k) clearances (all years, FDA)

23 (all years; only the last 3 years are listed here)

FDA classification definition

A cranial orthosis is a device that is intended for medical purposes to apply pressure to prominent regions of an infant's cranium in order to improve cranial symmetry and/or shape. A laser scanning accessory may be used to create a scan of the infant's head. Indicated for infants from 3 to 18 months of age, with moderate to severe nonsynostotic positional plagiocephaly, including infants with plagiocephalic-, brachycephalic-, and scaphocephalic-shaped heads.

Definition text from the FDA device classification database (U.S. federal government work, public domain).

510(k) clearances, last 3 years (2)

Last three years. Most recent: 2025-03-17.

2 summaries are archived here for direct download.