ARION

Powered Laser Surgical Instrument

WAVELIGHT LASER TECHNOLOGIE AG

The following data is part of a premarket notification filed by Wavelight Laser Technologie Ag with the FDA for Arion.

Pre-market Notification Details

• Device ID: K042474
• 510k Number: K042474
• Device Name: ARION
• Classification: Powered Laser Surgical Instrument
• Applicant: WAVELIGHT LASER TECHNOLOGIE AG FRANKFURTER STRASSE 229 Neu-isenburg, DE D-63263
• Contact: Thorsten Creter
• Correspondent: William J Sammons; UNDERWRITERS LABORATORIES, INC. 12 LABORATORY DR. Research Triangle, NC 27709
• Product Code: GEX
• CFR Regulation Number: 878.4810 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: Yes
• Combination Product: No
• Date Received: 2004-09-13
• Decision Date: 2004-09-29
• Summary: summary