FDA 510(k)

Innova Vision 히드로젤 (히오시필콘 A) 소프트 (수용성) 컨택렌즈

K-번호: K213119 · 2022-05-13

결정일2022-05-13

제품 코드LPL

자문 위원회의료장비 규제 텍스트 번역 OP

결정대체적으로 동일

기기 요약

Innova Vision Hydrogel (Hioxifilcon A) Soft (Hydrophilic) 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 2022-05-13 under 510(k) number K213119. 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 Hydrogel (Hioxifilcon A) Soft (Hydrophilic) Contact Lens?

Innova Vision Hydrogel (Hioxifilcon A) Soft (Hydrophilic) Contact Lens is a medical device that received FDA 510(k) clearance on 2022-05-13. The listed applicant is Innova Vision, Inc.. The 510(k) number is K213119.

When did Innova Vision Hydrogel (Hioxifilcon A) Soft (Hydrophilic) Contact Lens receive FDA 510(k) clearance?

Innova Vision Hydrogel (Hioxifilcon A) Soft (Hydrophilic) Contact Lens received FDA 510(k) clearance on 2022-05-13, under 510(k) number K213119.

Who is the listed applicant for Innova Vision Hydrogel (Hioxifilcon A) Soft (Hydrophilic) 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 Hydrogel (Hioxifilcon A) Soft (Hydrophilic) Contact Lens?

The FDA product code for Innova Vision Hydrogel (Hioxifilcon A) Soft (Hydrophilic) Contact Lens is LPL.

Innova Vision, Inc.를 신청인으로 등재한 기타 기록

K240519Innova Vision (inifilcon A) 실리콘 히드로젤 (수용성) 일일 착용 소프트 콘택트 렌즈 K232139Innova Vision (inifilcon A) 실리콘 히드로젤 소프트 (수용성) 컨택렌즈 K222954Innova Vision 히드로젤 (에타필콘 A) 소프트 (히드로필릭) 컨택렌즈

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