FDA 510(k)

에토스 아켈 (Hioxifilcon A) 일일 소프트 (수용성) 컨택 렌즈 (59% 물)

K-번호: K201268 · 2020-10-21

결정일2020-10-21

제품 코드LPL

자문 위원회의료장비 규제 텍스트 번역 OP

결정대체적으로 동일

기기 요약

Ethos Aquell (Hioxifilcon A) One-Day Soft (Hydrophilic) Contact Lenses (59% Water) is the device name listed in this FDA 510(k) record. The listed applicant is Plexus Optix, Inc.. It received FDA 510(k) clearance on 2020-10-21 under 510(k) number K201268. 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 Ethos Aquell (Hioxifilcon A) One-Day Soft (Hydrophilic) Contact Lenses (59% Water)?

Ethos Aquell (Hioxifilcon A) One-Day Soft (Hydrophilic) Contact Lenses (59% Water) is a medical device that received FDA 510(k) clearance on 2020-10-21. The listed applicant is Plexus Optix, Inc.. The 510(k) number is K201268.

When did Ethos Aquell (Hioxifilcon A) One-Day Soft (Hydrophilic) Contact Lenses (59% Water) receive FDA 510(k) clearance?

Ethos Aquell (Hioxifilcon A) One-Day Soft (Hydrophilic) Contact Lenses (59% Water) received FDA 510(k) clearance on 2020-10-21, under 510(k) number K201268.

Who is the listed applicant for Ethos Aquell (Hioxifilcon A) One-Day Soft (Hydrophilic) Contact Lenses (59% Water)?

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

What is the FDA product code for Ethos Aquell (Hioxifilcon A) One-Day Soft (Hydrophilic) Contact Lenses (59% Water)?

The FDA product code for Ethos Aquell (Hioxifilcon A) One-Day Soft (Hydrophilic) Contact Lenses (59% Water) is LPL.

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에토스 아켈 (Hioxifilcon A) 일일 소프트 (수용성) 컨택 렌즈 (59% 물)

기기 요약

자주 묻는 질문

관련 임상시험

관련 기기 (코드: LPL)

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