FDA 510(k)

Innova Vision (inifilcon A) 실리콘 히드로젤 (수용성) 일일 착용 소프트 콘택트 렌즈

K-번호: K240519 · 2024-04-17

결정일2024-04-17

제품 코드LPL

자문 위원회의료장비 규제 텍스트 번역 OP

결정대체적으로 동일

기기 요약

Innova Vision (inifilcon A) Silicone Hydrogel (Hydrophilic) Daily Wear Soft Contact Lens is the device name listed in this FDA 510(k) record. The listed applicant is Innova Vision, Inc.. It received FDA 510(k) clearance on 2024-04-17 under 510(k) number K240519. 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 Innova Vision (inifilcon A) Silicone Hydrogel (Hydrophilic) Daily Wear Soft Contact Lens?

Innova Vision (inifilcon A) Silicone Hydrogel (Hydrophilic) Daily Wear Soft Contact Lens is a medical device that received FDA 510(k) clearance on 2024-04-17. The listed applicant is Innova Vision, Inc.. The 510(k) number is K240519.

When did Innova Vision (inifilcon A) Silicone Hydrogel (Hydrophilic) Daily Wear Soft Contact Lens receive FDA 510(k) clearance?

Innova Vision (inifilcon A) Silicone Hydrogel (Hydrophilic) Daily Wear Soft Contact Lens received FDA 510(k) clearance on 2024-04-17, under 510(k) number K240519.

Who is the listed applicant for Innova Vision (inifilcon A) Silicone Hydrogel (Hydrophilic) Daily Wear Soft Contact Lens?

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

What is the FDA product code for Innova Vision (inifilcon A) Silicone Hydrogel (Hydrophilic) Daily Wear Soft Contact Lens?

The FDA product code for Innova Vision (inifilcon A) Silicone Hydrogel (Hydrophilic) Daily Wear Soft Contact Lens is LPL.

Innova Vision, Inc.를 신청인으로 등재한 기타 기록

K232139Innova Vision (inifilcon A) 실리콘 히드로젤 소프트 (수용성) 컨택렌즈 K222954Innova Vision 히드로젤 (에타필콘 A) 소프트 (히드로필릭) 컨택렌즈 K213119Innova Vision 히드로젤 (히오시필콘 A) 소프트 (수용성) 컨택렌즈

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