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: K090587
• 510k Number: K090587
• Device Name: STARLIGHT
• Classification: Orthosis, Cranial, Laser Scan
• Applicant: ORTHOMERICA PRODUCTS, INC. 6333 N. ORANGE BLOSSOM TRAIL Orlando, FL 32810
• Contact: Alan T Sandifer
• Correspondent: Alan T Sandifer; ORTHOMERICA PRODUCTS, INC. 6333 N. 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: 2009-03-04
• Decision Date: 2009-07-17
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
B15176007PA0	K090587	000
B15170907PA0	K090587	000
B15170407PA0	K090587	000
B15170307PA0	K090587	000