PEGASUS

Powered Laser Surgical Instrument

PFIZER LASER SYSTEMS

The following data is part of a premarket notification filed by Pfizer Laser Systems with the FDA for Pegasus.

Pre-market Notification Details

• Device ID: K885060
• 510k Number: K885060
• Device Name: PEGASUS
• Classification: Powered Laser Surgical Instrument
• Applicant: PFIZER LASER SYSTEMS 3 MORGAN Irvine, CA 92718
• Contact: Cozean, Phd
• Correspondent: Cozean, Phd; PFIZER LASER SYSTEMS 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: 1988-12-07
• Decision Date: 1989-06-02