FDA 510(k)

EyeGility™ Inserter for Preloaded enVista IOLs

K-번호: K242389 · 2024-10-10

결정일2024-10-10

제품 코드MSS

자문 위원회OP

결정Substantially Equivalent

기기 요약

EyeGility™ Inserter for Preloaded enVista IOLs is the device name listed in this FDA 510(k) record. The listed applicant is Bausch & Lomb, Incorporated. It received FDA 510(k) clearance on 2024-10-10 under 510(k) number K242389. 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 EyeGility™ Inserter for Preloaded enVista IOLs?

EyeGility™ Inserter for Preloaded enVista IOLs is a medical device that received FDA 510(k) clearance on 2024-10-10. The listed applicant is Bausch & Lomb, Incorporated. The 510(k) number is K242389.

When did EyeGility™ Inserter for Preloaded enVista IOLs receive FDA 510(k) clearance?

EyeGility™ Inserter for Preloaded enVista IOLs received FDA 510(k) clearance on 2024-10-10, under 510(k) number K242389.

Who is the listed applicant for EyeGility™ Inserter for Preloaded enVista IOLs?

The FDA 510(k) record lists Bausch & Lomb, Incorporated as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for EyeGility™ Inserter for Preloaded enVista IOLs?

The FDA product code for EyeGility™ Inserter for Preloaded enVista IOLs is MSS.

Bausch & Lomb, Incorporated를 신청인으로 등재한 기타 기록

K252052Stellaris Elite™ vision enhancement system (BL11145, BL14455, BL15455, SE14565, SE15565, SE14565E, SE15565E)K240169Stellaris Elite vision enhancement system (BL11145, BL14455, BL15455)K220613Bausch + Lomb (kalifilcon A) Soft (hydrophilic) Contact Lens, Bausch + Lomb (kalifilcon A) Soft (hydrophilic) Contact Lens for Astigmatism, and, Bausch + Lomb (kalifilcon A) Soft (hydrophilic) Contact Lens for Presbyopia K222541Bausch + Lomb Preservative Free Lubricating and Rewetting Drops K202932ABT12 다용도 솔루션 K210975Bausch + Lomb (kalifilcon A) Soft (hydrophilic) Contact Lens for Presbyopia

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