Product code OAN

Device name
Orthosis, Cranial, Laser Scan
Medical specialty
Neurology
Device class
2
Regulation number
882.5970
Review panel
NE
Implant
N
Life sustaining/supporting
N
GMP exempt
N
Third party review
N
Summary malfunction reporting
Eligible
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.
Source
FDA openFDA device classification dataset