ORION

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 Orion.

Pre-market Notification Details

• Device ID: K911288
• 510k Number: K911288
• Device Name: ORION
• Classification: Powered Laser Surgical Instrument
• Applicant: PFIZER LASER SYSTEMS 3 MORGAN Irvine, CA 92718
• Contact: Colette Cozean
• Correspondent: Colette Cozean; 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: 1991-02-28
• Decision Date: 1993-11-16