ORION

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 Orion.

Pre-market Notification Details

• Device ID: K113489
• 510k Number: K113489
• Device Name: ORION
• Classification: Powered Laser Surgical Instrument
• Applicant: ASCLEPION LASER TECHNOLOGIES GMBH BRUESSELER STR. 10 Jena, DE 07747
• Contact: Antje Katzer
• Correspondent: Antje Katzer; ASCLEPION LASER TECHNOLOGIES GMBH BRUESSELER STR. 10 Jena, DE 07747
• Product Code: GEX
• CFR Regulation Number: 878.4810 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2011-11-23
• Decision Date: 2012-07-27
• Summary: summary