ZERONA

Fat Reducing Low Level Laser

ERCHONIA CORPORATION

The following data is part of a premarket notification filed by Erchonia Corporation with the FDA for Zerona.

Pre-market Notification Details

• Device ID: K133718
• 510k Number: K133718
• Device Name: ZERONA
• Classification: Fat Reducing Low Level Laser
• Applicant: ERCHONIA CORPORATION 33 EAGLE LANE Littleton, CO 80127
• Contact: Kevin Walls
• Correspondent: Kevin Walls; ERCHONIA CORPORATION 33 EAGLE LANE Littleton, CO 80127
• Product Code: OLI
• CFR Regulation Number: 878.5400 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2013-12-04
• Decision Date: 2014-05-12