MULTISTAR

Powered Laser Surgical Instrument

ASCLEPION LASER TECHNOLOGIES GMBH

The following data is part of a premarket notification filed by Asclepion Laser Technologies Gmbh with the FDA for Multistar.

Pre-market Notification Details

• Device ID: K060455
• 510k Number: K060455
• Device Name: MULTISTAR
• Classification: Powered Laser Surgical Instrument
• Applicant: ASCLEPION LASER TECHNOLOGIES GMBH GOESCHWITZERSTRASSE 51-52 Jena, DE 07745
• Contact: Reinhard Thieme
• Correspondent: Reinhard Thieme; ASCLEPION LASER TECHNOLOGIES GMBH GOESCHWITZERSTRASSE 51-52 Jena, DE 07745
• Product Code: GEX
• CFR Regulation Number: 878.4810 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Special
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2006-02-22
• Decision Date: 2006-03-20
• Summary: summary