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Starlight

FDA 510(k)

Class II (US FDA 510(k))

510(k) K133250

by Orthomerica Products, Inc.

Identifiers

510(k) Number
K133250 FDA 510(k)
FDA Product Code
OAN FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 882.5970 FDA 510(k)
Regulation Number
882.5970 FDA 510(k)
Advisory Committee
Neurology FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Starlight is a cranial orthosis that redirects head growth to improve proportion and symmetry. It is intended for use on infants from 3 to 18 months of age with moderate-to-severe non-synostotic positional head shape deformities, including plagiocephalic, brachycephalic, and scaphocephalic-shaped heads.

The device is available in six specific orthoses pad configurations depending on the suture release procedure: bi-coronal, bi-lambdoidal, metopic, sagittal, uni-coronal, and unilambdoidal. It is supplied as a patient-specific cranial orthosis that applies mild pressure to prominent areas of the head. The device has FDA 510(k) clearance with product code OAN and is classified as a class II device.

Frequently asked questions

What is the Starlight cranial orthosis used for?

The Starlight is a cranial orthosis designed to redirect head growth and improve proportion and symmetry in infants aged 3 to 18 months who have moderate-to-severe non-synostotic positional head shape deformities, including plagiocephalic, brachycephalic, and scaphocephalic-shaped heads.

How many orthoses pad configurations are available for the Starlight?

The Starlight is available in six specific orthoses pad configurations depending on the suture release procedure: bi-coronal, bi-lambdoidal, metopic, sagittal, uni-coronal, and unilambdoidal. Each configuration is designed to address specific types of head shape deformities.

Is the Starlight cranial orthosis reusable or single-use?

The Starlight is supplied as a patient-specific cranial orthosis that applies mild pressure to prominent areas of the head. The device is designed for individual patient use, but the description does not specify whether it is single-use or reusable.

What is the regulatory status of the Starlight cranial orthosis?

The Starlight has FDA 510(k) clearance with product code OAN and is classified as a class II device. It was cleared through the traditional 510(k) pathway on January 16, 2014, with the K number K133250.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Starlight® PRO - Orthomerica Products, Inc., Home - Orthomerica Products, Inc., ORTHOMERICA PRODUCTS, INC. 760.01A STARlight® Bi-Valve - RevMed, STARLIGHT by ORTHOMERICA PRODUCTS, INC. | FDA 510(k) Summary

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Orthomerica Products, Inc.

Sources (1)

  • FDA 510(k) K133250 24 fields · synced Oct 1, 2026