CENTAURI

Laser, Ophthalmic

PFIZER LASER SYSTEMS

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

Pre-market Notification Details

• Device ID: K905141
• 510k Number: K905141
• Device Name: CENTAURI
• Classification: Laser, Ophthalmic
• 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: HQF
• CFR Regulation Number: 886.4390 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1990-11-15
• Decision Date: 1991-02-11