FDA 510(k)

AQUASPLASH (Polymacon) 소프트 (수분 유도성) 일일 착용隐形眼镜

K-번호: K210609 · 2021-04-27

결정일2021-04-27

제품 코드LPL

자문 위원회OP

결정Substantially Equivalent

기기 요약

AQUASPLASH (Polymacon) Soft (Hydrophilic) Daily Wear Contact Lens is the device name listed in this FDA 510(k) record. The listed applicant is Vp Optics. It received FDA 510(k) clearance on 2021-04-27 under 510(k) number K210609. 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 AQUASPLASH (Polymacon) Soft (Hydrophilic) Daily Wear Contact Lens?

AQUASPLASH (Polymacon) Soft (Hydrophilic) Daily Wear Contact Lens is a medical device that received FDA 510(k) clearance on 2021-04-27. The listed applicant is Vp Optics. The 510(k) number is K210609.

When did AQUASPLASH (Polymacon) Soft (Hydrophilic) Daily Wear Contact Lens receive FDA 510(k) clearance?

AQUASPLASH (Polymacon) Soft (Hydrophilic) Daily Wear Contact Lens received FDA 510(k) clearance on 2021-04-27, under 510(k) number K210609.

Who is the listed applicant for AQUASPLASH (Polymacon) Soft (Hydrophilic) Daily Wear Contact Lens?

The FDA 510(k) record lists Vp Optics as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for AQUASPLASH (Polymacon) Soft (Hydrophilic) Daily Wear Contact Lens?

The FDA product code for AQUASPLASH (Polymacon) Soft (Hydrophilic) Daily Wear Contact Lens is LPL.

관련 기기 (코드: LPL)

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FDA Open API에서 수집된 데이터입니다. 가장 정확하고 공인된 정보는 항상 공식 레코드를 참조하시기 바랍니다.

기기 요약

자주 묻는 질문

관련 임상시험

관련 기기 (코드: LPL)

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