FDA 510(k)

하루 평평한 팩 (하이오시필콘 A) 일일 disposable 소프트 컨택트 렌즈

K-번호: K180819 · 2018-05-16

결정일2018-05-16

제품 코드LPL

자문 위원회의료장비 규제 텍스트 번역 OP

결정Substantially Equivalent

기기 요약

One Day Flat Pack (hioxifilcon A) Daily Disposable Soft Contact Lens is the device name listed in this FDA 510(k) record. The listed applicant is Menicon Co, Ltd.. It received FDA 510(k) clearance on 2018-05-16 under 510(k) number K180819. The device is classified under product code LPL. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

자주 묻는 질문

What is the One Day Flat Pack (hioxifilcon A) Daily Disposable Soft Contact Lens?

One Day Flat Pack (hioxifilcon A) Daily Disposable Soft Contact Lens is a medical device that received FDA 510(k) clearance on 2018-05-16. The listed applicant is Menicon Co, Ltd.. The 510(k) number is K180819.

When did One Day Flat Pack (hioxifilcon A) Daily Disposable Soft Contact Lens receive FDA 510(k) clearance?

One Day Flat Pack (hioxifilcon A) Daily Disposable Soft Contact Lens received FDA 510(k) clearance on 2018-05-16, under 510(k) number K180819.

Who is the listed applicant for One Day Flat Pack (hioxifilcon A) Daily Disposable Soft Contact Lens?

The FDA 510(k) record lists Menicon Co, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for One Day Flat Pack (hioxifilcon A) Daily Disposable Soft Contact Lens?

The FDA product code for One Day Flat Pack (hioxifilcon A) Daily Disposable Soft Contact Lens is LPL.

Menicon Co, Ltd.를 신청인으로 등재한 기타 기록

K262495미루 1day 아업사이드 (미드아필콘 A)K253795메니세프트 3% 수소산화물 청소 및 소독 용액 K193399미루 1day 아업사이드 (미드아필콘 A)K191872메니콘 3% 히드로젠 Peroxide 청소 및 소독 용액 K180004메니콘 ASRB (asmofilcon A) 실리콘 히드로젤 소프트 컨택트 렌즈 K173136메니콘 프로젠트 테이프 렌즈용 단백질 제거제

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