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: K081994
• 510k Number: K081994
• 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: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2008-07-14
• Decision Date: 2008-09-12
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
B15170903PA0	K081994	000
B15170901PA0	K081994	000
B15170403PA0	K081994	000
B15170401PA0	K081994	000
B15170303PA0	K081994	000
B15170301PA0	K081994	000