AURORA

Powered Laser Surgical Instrument

PREMIER LASER SYSTEMS, INC.

The following data is part of a premarket notification filed by Premier Laser Systems, Inc. with the FDA for Aurora.

Pre-market Notification Details

• Device ID: K981379
• 510k Number: K981379
• Device Name: AURORA
• Classification: Powered Laser Surgical Instrument
• Applicant: PREMIER LASER SYSTEMS, INC. 3 MORGAN Irvine, CA 92718
• Contact: Beth A Soper
• Correspondent: Beth A Soper; PREMIER LASER SYSTEMS, INC. 3 MORGAN Irvine, CA 92718
• Product Code: GEX
• CFR Regulation Number: 878.4810 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1998-04-16
• Decision Date: 1998-11-23