# K140353: Starband and Starlight

- Pathway: 510(k) (Traditional)
- Applicant: Orthomerica Products, Inc.
- Decided: Jun 6, 2014 after 114 days
- Product code: MVA (Orthosis, Cranial)
- Device class: 2
- Regulation: 21 CFR 882.5970
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 7 generations back to K001167 (2000). 15 ancestors in all.
13 later devices descend from it; 2 cite it directly.
0 of 29 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K124023: Starband, Orthomerica Products, Inc. (2013) Summary page 2.
- K133250: Starlight, Orthomerica Products, Inc. (2014) Summary page 2.
- K014012: Doc Band, Cranial Technologies, Inc. (2002) Summary page 3.

## Most influential descendants
- K141842: Starband, Starlight (2014), 10 descendants of its own
- K151147: STARband, STARlight (2015), 9 descendants of its own
- K151979: STARband, STARlight (2015), 8 descendants of its own
- K161138: St. Louis Band (2016), 4 descendants of its own
- K180109: STARband, STARlight, St. Louis Band (2018), 3 descendants of its own

## Indications for use
The STARband and STARlight is intended for medical purposes for use an infants from 3 to 18 months of age, with moderate-to-severe non-synostotic positional plagiocephaly, including infants with plagiocephalic-, brachycephalic- and scaphocephalic-shaped heads by applying mild pressure to prominent regions of the infant's cranium in order to improve cranial symmetry and/or shape. The device is also indicated for adjunctive use for infants from 3 to 18 months of age whose synostosis has been surgically corrected, but who still have moderate-to-severe cranial deformities including plagiocephalic-, brachycephalic- and scaphocephalic-shaped heads.

Source page: https://510kreport.com/device/K140353
Methodology: https://510kreport.com/methodology