ALLY Adaptive Cataract Treatment System

Ophthalmic Femtosecond Laser

Lensar, Inc.

The following data is part of a premarket notification filed by Lensar, Inc. with the FDA for Ally Adaptive Cataract Treatment System.

Pre-market Notification Details

• Device ID: K220259
• 510k Number: K220259
• Device Name: ALLY Adaptive Cataract Treatment System
• Classification: Ophthalmic Femtosecond Laser
• Applicant: Lensar, Inc. 2800 Discovery Drive, Suite 100 Orlando, FL 32826
• Contact: Keith Peck
• Correspondent: Keith Peck; Lensar, Inc. 2800 Discovery Drive, Suite 100 Orlando, FL 32826
• Product Code: OOE
• CFR Regulation Number: 886.4390 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2022-01-31
• Decision Date: 2022-06-09

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
10867744000157	K220259	000