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: K082945
• 510k Number: K082945
• Device Name: STARLIGHT
• Classification: Orthosis, Cranial, Laser Scan
• Applicant: ORTHOMERICA PRODUCTS, INC. 6333 NORTH ORANGE BLOSSOM TRAIL Orlando, FL 32810
• Contact: Alan T Sandifer
• Correspondent: Alan T Sandifer; ORTHOMERICA PRODUCTS, INC. 6333 NORTH ORANGE BLOSSOM TRAIL Orlando, FL 32810
• Product Code: OAN
• CFR Regulation Number: 882.5970 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Special
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2008-10-02
• Decision Date: 2008-10-31

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
B15176003PA0	K082945	000
B15176003A0	K082945	000
B15176001PA0	K082945	000
B15176001A0	K082945	000