OAN — Orthosis, Cranial, Laser Scan Class II
FDA product code OAN covers "Orthosis, Cranial, Laser Scan", a Class II medical device regulated under 21 CFR 882.5970. Submissions are reviewed by the Neurology panel. At least 20 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- OAN
- Device Class
- Class II
- Regulation Number
- 882.5970
- Submission Type
- Review Panel
- NE
- Medical Specialty
- Neurology
- Implant
- No
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.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K244056 | cranial technologies | DOC Band 3D | March 17, 2025 |
| K240466 | orthomerica products | STARband 3D | March 15, 2024 |
| K211376 | orthomerica products | STARband | August 17, 2021 |
| K203098 | orthomerica products | STARband, STARlight, St. Louis Band | April 27, 2021 |
| K180109 | orthomerica products | STARband, STARlight, St. Louis Band | March 1, 2018 |
| K161138 | orthomerica products | St. Louis Band | July 20, 2016 |
| K151979 | orthomerica products | STARband, STARlight | September 18, 2015 |
| K151147 | orthomerica products | STARband, STARlight | July 1, 2015 |
| K142141 | orthomerica products | STARBAND, STARLIGHT | April 23, 2015 |
| K133250 | orthomerica products | STARLIGHT | January 16, 2014 |
| K124023 | orthomerica products | STARBAND | June 10, 2013 |
| K090587 | orthomerica products | STARLIGHT | July 17, 2009 |
| K081787 | biosculptor corporation | CAMLAB CRANIAL ORTHOSIS HELMET | January 27, 2009 |
| K082950 | orthomerica products | STARBAND | December 5, 2008 |
| K082945 | orthomerica products | STARLIGHT | October 31, 2008 |
| K081994 | orthomerica products | STARLIGHT | September 12, 2008 |
| K072862 | boston brace intl | BOSTON-BAND CRANIAL REMODLING ORTHOSIS | January 22, 2008 |
| K072566 | hanger prosthetics and orthotics | HANGER CRANIAL BAND | January 9, 2008 |
| K063098 | boston brace intl | STATIC CRANIOPLASTY ORTHOSIS | April 11, 2007 |
| K021918 | orthomerica products | CLARREN HELMET (ORTHOMERICA) | July 25, 2002 |