FDA 510(k)

ELITA™ 펨토초 레이저 시스템, ELITA™ 환자 인터페이스

K-번호: K223566 · 2023-04-14

신청자Johnson & Johnson Surgical Vision, Inc.

결정일2023-04-14

제품 코드OOE

자문 위원회의료장비 규제 텍스트 번역 OP

결정Substantially Equivalent

기기 요약

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.

자주 묻는 질문

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.

Johnson & Johnson Surgical Vision, Inc.를 신청인으로 등재한 기타 기록

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