510(k) K244056
K244056 is an FDA 510(k) premarket notification submitted by Cranial Technologies, Inc. for the device "DOC Band 3D". The FDA issued a decision of Substantially Equivalent on March 17, 2025. The device falls under product code OAN (Orthosis, Cranial, Laser Scan), a Class II device regulated under 21 CFR 882.5970. Cranial Technologies, Inc. has at least 3 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 17, 2025
- Date Received
- December 31, 2024
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Orthosis, Cranial, Laser Scan
- Device Class
- Class II
- Regulation Number
- 882.5970
- Review Panel
- NE
- Submission Type
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.