FDA 510(k)

CLAREON MONARCH IV IOL 전달 시스템

K-번호: K212039 · 2021-08-23

결정일2021-08-23

제품 코드MSS

자문 위원회의료장비 규제 텍스트 번역 OP

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기기 요약

CLAREON MONARCH IV IOL Delivery System is the device name listed in this FDA 510(k) record. The listed applicant is Alcon Laboratories, Inc.. It received FDA 510(k) clearance on 2021-08-23 under 510(k) number K212039. The device is classified under product code MSS. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

자주 묻는 질문

What is the CLAREON MONARCH IV IOL Delivery System?

CLAREON MONARCH IV IOL Delivery System is a medical device that received FDA 510(k) clearance on 2021-08-23. The listed applicant is Alcon Laboratories, Inc.. The 510(k) number is K212039.

When did CLAREON MONARCH IV IOL Delivery System receive FDA 510(k) clearance?

CLAREON MONARCH IV IOL Delivery System received FDA 510(k) clearance on 2021-08-23, under 510(k) number K212039.

Who is the listed applicant for CLAREON MONARCH IV IOL Delivery System?

The FDA 510(k) record lists Alcon Laboratories, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CLAREON MONARCH IV IOL Delivery System?

The FDA product code for CLAREON MONARCH IV IOL Delivery System is MSS.

Alcon Laboratories, Inc.를 신청인으로 등재한 기타 기록

K254052DAILIES TOTAL1®; DAILIES TOTAL1® 다중축 K252682LenSx 레이저 시스템 (8065000944)K243896LenSx 레이저 시스템 (8065998162)K243909프레시온1; 프레시온1 아스타igmatism용; 다일리즈 토탈1; 다일리즈 토탈1 아스타igmatism용; 다일리즈 토탈1 다중축; 다일리즈 토탈1 다중축 토릭 K242184Alcon 27GA Chandelier (8065000252); Alcon 27+ DS Wide Angle Endoilluminator (8065000253); Alcon 27+ DS Endoilluminator (8065000256);K233876UNIFY VCS (8065000296); UNIFY CS (8065000297)

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