OAN — Orthosis, Cranial, Laser Scan Class II
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 |