PEGASUS

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 Pegasus.

Pre-market Notification Details

• Device ID: K925178
• 510k Number: K925178
• Device Name: PEGASUS
• Classification: Powered Laser Surgical Instrument
• Applicant: PREMIER LASER SYSTEMS, INC. #3 MORGAN Irvine, CA 92618
• Contact: Judy E Mazza
• Correspondent: Judy E Mazza; PREMIER LASER SYSTEMS, INC. #3 MORGAN Irvine, CA 92618
• Product Code: GEX
• CFR Regulation Number: 878.4810 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1992-10-14
• Decision Date: 1994-03-14