DeviceClearance

Product code OAN— Neurology

STARLIGHT

Classification name
Orthosis, Cranial, Laser Scan
Device class
Class 2
Regulation
21 CFR 882.5970
Advisory panel
Neurology
Total cleared
23
First cleared
Most recent

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.”

— U.S. Food and Drug Administration, device classification record for product code OAN under 21 CFR 882.5970, via openFDA

Market context for product code OAN

FDA has cleared 23 devices under product code OAN between 2001 and 2025, filed by 5 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Clearances per year

Top applicants under product code OAN

Recent clearances under product code OAN

Data sourced from openFDA. This site is unofficial and independent of the FDA.