# K021207: Starlight

- Pathway: 510(k) (Traditional)
- Applicant: Orthomerica Products, Inc.
- Decided: Jul 9, 2002 after 84 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: 1 generation back to K001167 (2000). 1 ancestor in all.
25 later devices descend from it; 1 cites it directly.
0 of 27 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K001167: Opi Band, Orthomerica Products, Inc. (2000) Summary page 1.

## Most influential descendants
- K081994: Starlight (2008), 24 descendants of its own
- K082950: Starband (2008), 21 descendants of its own
- K111609: Boston Band (2011), 16 descendants of its own
- K082945: Starlight (2008), 16 descendants of its own
- K124023: Starband (2013), 15 descendants of its own

## Indications for use
The STARlight is available by prescription only and intended for use in infants from three 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.

Source page: https://510kreport.com/device/K021207
Methodology: https://510kreport.com/methodology