FDA 510(k)

체질 유화제 포함 하이드라-PEG (에타필콘 A) 소프트 (수용성) 일일 착용隐形眼镜

K-번호: K171125 · 2017-10-18

결정일2017-10-18

제품 코드LPL

자문 위원회의료장비 규제 텍스트 번역 OP

결정대체적으로 동일

기기 요약

Tangible Hydrogel w/ Hydra-PEG (etafilcon A) Soft (Hydrophilic) Daily Wear Contact Lens is the device name listed in this FDA 510(k) record. The listed applicant is Tangible Science, LLC. It received FDA 510(k) clearance on 2017-10-18 under 510(k) number K171125. 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 Tangible Hydrogel w/ Hydra-PEG (etafilcon A) Soft (Hydrophilic) Daily Wear Contact Lens?

Tangible Hydrogel w/ Hydra-PEG (etafilcon A) Soft (Hydrophilic) Daily Wear Contact Lens is a medical device that received FDA 510(k) clearance on 2017-10-18. The listed applicant is Tangible Science, LLC. The 510(k) number is K171125.

When did Tangible Hydrogel w/ Hydra-PEG (etafilcon A) Soft (Hydrophilic) Daily Wear Contact Lens receive FDA 510(k) clearance?

Tangible Hydrogel w/ Hydra-PEG (etafilcon A) Soft (Hydrophilic) Daily Wear Contact Lens received FDA 510(k) clearance on 2017-10-18, under 510(k) number K171125.

Who is the listed applicant for Tangible Hydrogel w/ Hydra-PEG (etafilcon A) Soft (Hydrophilic) Daily Wear Contact Lens?

The FDA 510(k) record lists Tangible Science, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Tangible Hydrogel w/ Hydra-PEG (etafilcon A) Soft (Hydrophilic) Daily Wear Contact Lens?

The FDA product code for Tangible Hydrogel w/ Hydra-PEG (etafilcon A) Soft (Hydrophilic) Daily Wear Contact Lens is LPL.

Tangible Science, LLC를 신청인으로 등재한 기타 기록

K172692고체 히드로젤과 고체 포리머 (에타필콘 A) 소프트 (수용성) 일일 교환형 콘택트 렌즈

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