STARlight® PRO

Basic Information

• Brand Name: STARlight® PRO
• Primary DI: B15176607PA0
• Version / Model: 766.07PA
• Catalog Number: 766.07PA
• Company Name: ORTHOMERICA PRODUCTS, INC.
• Labeler DUNS: 604405373
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-06-29
• Public Version: 1
• Public Version Date: 2023-07-07
• Public Version Status: New
• Public Device Record Key: 6c9f0747-38c7-48b0-811a-6e01f4ebc986

Device Description

The STARlight® PRO is a patient specific cranial orthosis that redirects the head growth to improve proportion and symmetry. It is intended 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. The STARlight® PRO is made of clear Surlyn plastic or clear co-polyester plastic and may contain optional Aliplast foam (closed cell polyethylene) padding and/or Reston (polyurethane) foam. It utilizes two side openings and is held in place by a Velcro® straps across the side openings.

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
MVA	Orthosis, Cranial	Neurology	882.5970	2
OAN	Orthosis, Cranial, Laser Scan	Neurology	882.5970	2

GMDN Terms

Code	Name	Definition	Implantable	Status
62265	Cranial orthosis	A custom-made helmet-like device intended to be worn on the head of an infant with an abnormal head shape (e.g., due to plagiocephaly, brachycephaly, scaphocephaly), or after craniosynostosis repair surgery, to apply pressure to the cranium and improve cranial symmetry/shape during growth over a period of months. It is made of durable materials (e.g., plastic, solid foam) and is designed with patient-specific characteristics (e.g., size, shape) based on head measurements (e.g., clinical pictures, 3-D scans, casts). It is typically worn during daily activities and sleep. This is a single-patient device that can be reapplied during the treatment period (reusable) before being discarded.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	B15176607PA0	HIBCC

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K151147	000