LUCIA

Lamp, Infrared, Therapeutic Heating

MERIDIAN CO., LTD.

The following data is part of a premarket notification filed by Meridian Co., Ltd. with the FDA for Lucia.

Pre-market Notification Details

• Device ID: K102375
• 510k Number: K102375
• Device Name: LUCIA
• Classification: Lamp, Infrared, Therapeutic Heating
• Applicant: MERIDIAN CO., LTD. 3550 SW 148 AVENUE SUITE 110 Miramar, FL 33027
• Contact: Vinod Podichetty
• Correspondent: Vinod Podichetty; MERIDIAN CO., LTD. 3550 SW 148 AVENUE SUITE 110 Miramar, FL 33027
• Product Code: ILY
• CFR Regulation Number: 890.5500 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2010-08-20
• Decision Date: 2011-02-25
• Summary: summary