FDA 510(k)

메트로 soft, 실리콘 히드로젤 일일 착용 부드러운隐形眼镜 (efrofilcon A)

K-번호: K233221 · 2024-02-06

결정일2024-02-06

제품 코드LPL

자문 위원회의료장비 규제 텍스트 번역 OP

결정Substantially Equivalent

기기 요약

Metro Soft, Silicone Hydrogel Daily Wear Soft Contact Lens (efrofilcon A) is the device name listed in this FDA 510(k) record. The listed applicant is Metro Optics of Austin, Inc.. It received FDA 510(k) clearance on 2024-02-06 under 510(k) number K233221. 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 Metro Soft, Silicone Hydrogel Daily Wear Soft Contact Lens (efrofilcon A)?

Metro Soft, Silicone Hydrogel Daily Wear Soft Contact Lens (efrofilcon A) is a medical device that received FDA 510(k) clearance on 2024-02-06. The listed applicant is Metro Optics of Austin, Inc.. The 510(k) number is K233221.

When did Metro Soft, Silicone Hydrogel Daily Wear Soft Contact Lens (efrofilcon A) receive FDA 510(k) clearance?

Metro Soft, Silicone Hydrogel Daily Wear Soft Contact Lens (efrofilcon A) received FDA 510(k) clearance on 2024-02-06, under 510(k) number K233221.

Who is the listed applicant for Metro Soft, Silicone Hydrogel Daily Wear Soft Contact Lens (efrofilcon A)?

The FDA 510(k) record lists Metro Optics of Austin, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Metro Soft, Silicone Hydrogel Daily Wear Soft Contact Lens (efrofilcon A)?

The FDA product code for Metro Soft, Silicone Hydrogel Daily Wear Soft Contact Lens (efrofilcon A) is LPL.

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메트로 soft, 실리콘 히드로젤 일일 착용 부드러운隐形眼镜 (efrofilcon A)

기기 요약

자주 묻는 질문

관련 임상시험

관련 기기 (코드: LPL)

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