OAN
23 FDA 510(k) clearances · Product code
84 daysmedian time to decision
195 days90th percentile
23clearances measured
FDA profile
- Official device name
- Orthosis, Cranial, Laser Scan
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 882.5970
- Medical specialty
- Neurology
- FDA 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.
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| Record | Firm | Date |
|---|---|---|
| DOC Band 3D (K244056) | Cranial Technologies, Inc. | 2025-03-17 |
| STARband 3D (K240466) | Orthomerica Products, Inc. | 2024-03-15 |
| STARband (K211376) | Orthomerica Products, Inc. | 2021-08-17 |
| STARband, STARlight, St. Louis Band (K203098) | Orthomerica Products, Inc. | 2021-04-27 |
| STARband, STARlight, St. Louis Band (K180109) | Orthomerica Products, Inc. | 2018-03-01 |
| St. Louis Band (K161138) | Orthomerica Products, Inc. | 2016-07-20 |
| STARband, STARlight (K151979) | Orthomerica Products, Inc. | 2015-09-18 |
| STARband, STARlight (K151147) | Orthomerica Products, Inc. | 2015-07-01 |
| STARBAND, STARLIGHT (K142141) | Orthomerica Products, Inc. | 2015-04-23 |
| STARLIGHT (K133250) | Orthomerica Products, Inc. | 2014-01-16 |
| STARBAND (K124023) | Orthomerica Products, Inc. | 2013-06-10 |
| STARLIGHT (K090587) | Orthomerica Products, Inc. | 2009-07-17 |
| CAMLAB CRANIAL ORTHOSIS HELMET (K081787) | Biosculptor Corporation | 2009-01-27 |
| STARBAND (K082950) | Orthomerica Products, Inc. | 2008-12-05 |
| STARLIGHT (K082945) | Orthomerica Products, Inc. | 2008-10-31 |
| STARLIGHT (K081994) | Orthomerica Products, Inc. | 2008-09-12 |
| BOSTON-BAND CRANIAL REMODLING ORTHOSIS (K072862) | Boston Brace Intl., Inc. | 2008-01-22 |
| HANGER CRANIAL BAND (K072566) | Hanger Prosthetics & Orthotics, Inc. | 2008-01-09 |
| STATIC CRANIOPLASTY ORTHOSIS (K063098) | Boston Brace Intl., Inc. | 2007-04-11 |
| CLARREN HELMET (ORTHOMERICA) (K021918) | Orthomerica Products, Inc. | 2002-07-25 |
| STARLIGHT (K021207) | Orthomerica Products, Inc. | 2002-07-09 |
| DOC BAND (K014012) | Cranial Technologies, Inc. | 2002-01-28 |
| STARBAND CRANIAL ORTHOSIS (K011350) | Orthomerica Products, Inc. | 2001-07-03 |
Track OAN automatically
Every clearance here is in the API, with alerts when new ones post.