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: K021207
• 510k Number: K021207
• Device Name: STARLIGHT
• Classification: Orthosis, Cranial, Laser Scan
• Applicant: ORTHOMERICA PRODUCTS, INC. 6333 NORTH ORANGE BLOSSOM TRAIL Orlando, FL 32810
• Contact: Deanna Fish
• Correspondent: Deanna Fish; 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: 2002-04-16
• Decision Date: 2002-07-09
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
B15170903A0	K021207	000
B15170901A0	K021207	000
B15170403A0	K021207	000
B15170401A0	K021207	000
B15170303A0	K021207	000
B15170301A0	K021207	000