FDA 510(k)

비스코 (올리필콘 A) 소프트 콘택트 렌즈

K-번호: K160245 · 2016-10-24

결정일2016-10-24

제품 코드LPL

자문 위원회의료장비 규제 텍스트 번역 OP

결정대체적으로 동일

기기 요약

Visco (olifilcon A) soft contact lens is the device name listed in this FDA 510(k) record. The listed applicant is Visco Vision, Inc.. It received FDA 510(k) clearance on 2016-10-24 under 510(k) number K160245. 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 Visco (olifilcon A) soft contact lens?

Visco (olifilcon A) soft contact lens is a medical device that received FDA 510(k) clearance on 2016-10-24. The listed applicant is Visco Vision, Inc.. The 510(k) number is K160245.

When did Visco (olifilcon A) soft contact lens receive FDA 510(k) clearance?

Visco (olifilcon A) soft contact lens received FDA 510(k) clearance on 2016-10-24, under 510(k) number K160245.

Who is the listed applicant for Visco (olifilcon A) soft contact lens?

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

What is the FDA product code for Visco (olifilcon A) soft contact lens?

The FDA product code for Visco (olifilcon A) soft contact lens is LPL.

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