STARLIGHT

Orthosis, Cranial, Laser Scan

ORTHOMERICA PRODUCTS, INC.

The following data is part of a premarket notification filed by Orthomerica Products, Inc. with the FDA for Starlight.

Pre-market Notification Details

• Device ID: K133250
• 510k Number: K133250
• Device Name: STARLIGHT
• Classification: Orthosis, Cranial, Laser Scan
• Applicant: ORTHOMERICA PRODUCTS, INC. 6333 North Orange Blossom Trail Orlando, FL 32810
• Contact: David L Hooper
• Correspondent: David L Hooper; ORTHOMERICA PRODUCTS, INC. 6333 North Orange Blossom Trail Orlando, FL 32810
• Product Code: OAN
• CFR Regulation Number: 882.5970 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2013-10-22
• Decision Date: 2014-01-16
• Summary: summary