FDA 510(k) Applications for Medical Device Product Code "OAN"
(Orthosis, Cranial, Laser Scan)
| FDA 510(k) Number | Applicant | Device Name | Decision Date |
| K081787 | BIOSCULPTOR CORPORATION | CAMLAB CRANIAL ORTHOSIS HELMET | 01/27/2009 |
| K072862 | BOSTON BRACE INTL., INC. | BOSTON-BAND CRANIAL REMODLING ORTHOSIS | 01/22/2008 |
| K063098 | BOSTON BRACE INTL., INC. | STATIC CRANIOPLASTY ORTHOSIS | 04/11/2007 |
| K014012 | CRANIAL TECHNOLOGIES, INC. | DOC BAND | 01/28/2002 |
| K244056 | Cranial Technologies, Inc. | DOC Band 3D | 03/17/2025 |
| K072566 | HANGER PROSTHETICS & ORTHOTICS, INC. | HANGER CRANIAL BAND | 01/09/2008 |
| K211376 | Orthomerica Products Inc. | STARband | 08/17/2021 |
| K240466 | Orthomerica Products Inc. | STARband 3D | 03/15/2024 |
| K203098 | Orthomerica Products Inc. | STARband, STARlight, St. Louis Band | 04/27/2021 |
| K180109 | Orthomerica Products, Inc | STARband, STARlight, St. Louis Band | 03/01/2018 |
| K021918 | ORTHOMERICA PRODUCTS, INC. | CLARREN HELMET (ORTHOMERICA) | 07/25/2002 |
| K161138 | ORTHOMERICA PRODUCTS, INC. | St. Louis Band | 07/20/2016 |
| K124023 | ORTHOMERICA PRODUCTS, INC. | STARBAND | 06/10/2013 |
| K082950 | ORTHOMERICA PRODUCTS, INC. | STARBAND | 12/05/2008 |
| K011350 | ORTHOMERICA PRODUCTS, INC. | STARBAND CRANIAL ORTHOSIS | 07/03/2001 |
| K142141 | ORTHOMERICA PRODUCTS, INC. | STARBAND, STARLIGHT | 04/23/2015 |
| K151147 | ORTHOMERICA PRODUCTS, INC. | STARband, STARlight | 07/01/2015 |
| K151979 | ORTHOMERICA PRODUCTS, INC. | STARband, STARlight | 09/18/2015 |
| K081994 | ORTHOMERICA PRODUCTS, INC. | STARLIGHT | 09/12/2008 |
| K090587 | ORTHOMERICA PRODUCTS, INC. | STARLIGHT | 07/17/2009 |
| K021207 | ORTHOMERICA PRODUCTS, INC. | STARLIGHT | 07/09/2002 |
| K082945 | ORTHOMERICA PRODUCTS, INC. | STARLIGHT | 10/31/2008 |
| K133250 | ORTHOMERICA PRODUCTS, INC. | STARLIGHT | 01/16/2014 |
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