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 a medical device manufactured by Johnson & Johnson Surgical Vision, Inc.. It received FDA 510(k) clearance on 2023-04-14 under approval 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. It is manufactured by Johnson & Johnson Surgical Vision, Inc.. The 510(k) number is K223566.

When was ELITA Femtosecond Laser System, ELITA Patient Interface approved by the FDA?

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

What company makes ELITA Femtosecond Laser System, ELITA Patient Interface?

ELITA Femtosecond Laser System, ELITA Patient Interface is manufactured by Johnson & Johnson Surgical Vision, Inc..

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.