FDA 510(k)

ELITA™ Femtosecond Laser System, ELITA™ Patient Interface

K-Number: K223566 · 2023-04-14

ApplicantJohnson & Johnson Surgical Vision, Inc.

Decision Date2023-04-14

Product CodeOOE

Advisory CommitteeOP

DecisionSubstantially Equivalent

Device Summary

ELITA™ Femtosecond Laser System, ELITA™ Patient Interface is the device name listed in this FDA 510(k) record. The listed applicant is Johnson & Johnson Surgical Vision, Inc.. It received FDA 510(k) clearance on 2023-04-14 under 510(k) number K223566. The device is classified under product code OOE. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ELITA™ Femtosecond Laser System, ELITA™ Patient Interface?

ELITA™ Femtosecond Laser System, ELITA™ Patient Interface is a medical device that received FDA 510(k) clearance on 2023-04-14. The listed applicant is Johnson & Johnson Surgical Vision, Inc.. The 510(k) number is K223566.

When did ELITA™ Femtosecond Laser System, ELITA™ Patient Interface receive FDA 510(k) clearance?

ELITA™ Femtosecond Laser System, ELITA™ Patient Interface received FDA 510(k) clearance on 2023-04-14, under 510(k) number K223566.

Who is the listed applicant for ELITA™ Femtosecond Laser System, ELITA™ Patient Interface?

The FDA 510(k) record lists Johnson & Johnson Surgical Vision, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ELITA™ Femtosecond Laser System, ELITA™ Patient Interface?

The FDA product code for ELITA™ Femtosecond Laser System, ELITA™ Patient Interface is OOE.

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.