# K180109: STARband, STARlight, St. Louis Band

- Pathway: 510(k) (Special)
- Applicant: Orthomerica Products, Inc.
- Decided: Mar 1, 2018 after 44 days
- Product code: OAN (Orthosis, Cranial, Laser Scan)
- 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: 12 generations back to K001167 (2000). 22 ancestors in all.
3 later devices descend from it; 3 cite it directly.
0 of 26 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K151979: STARband, STARlight, Orthomerica Products, Inc. (2015) Summary page 4.
- K161138: St. Louis Band, Orthomerica Products, Inc. (2016) Summary page 4.

## Most influential descendants
- K213587: MyCRO Band (2022), 0 descendants of its own
- K193383: SnugKap (2021), 0 descendants of its own
- K201426: MyCRO Band (2021), 0 descendants of its own

## Indications for use
The STARband, STARlight, and St. Louis Band are intended for medical purposes for use on 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. These devices are 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/K180109
Methodology: https://510kreport.com/methodology