The following data is part of a premarket notification filed by Orthomerica Products, Inc. with the FDA for Starband, Starlight.
| Device ID | K142141 |
| 510k Number | K142141 |
| Device Name: | STARBAND, STARLIGHT |
| Classification | Orthosis, Cranial, Laser Scan |
| Applicant | ORTHOMERICA PRODUCTS, INC. 6333 North Orange Blossom Trail Orlando, FL 32810 |
| Contact | David L.hooper |
| Correspondent | David L.hooper ORTHOMERICA PRODUCTS, INC. 6333 North Orange Blossom Trail Orlando, FL 32810 |
| Product Code | OAN |
| CFR Regulation Number | 882.5970 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-08-05 |
| Decision Date | 2015-04-23 |
| Summary: | summary |