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FDA 510(k)

EYEREVE (hioxifilcon D) Soft (hydrophilic) Contact Lens for Daily Wear

K-번호: K161124 · 2016-08-26

신청자Vision Science Co., Ltd.
결정일2016-08-26
제품 코드LPL
자문 위원회OP
결정Substantially Equivalent

기기 요약

EYEREVE (hioxifilcon D) Soft (hydrophilic) Contact Lens for Daily Wear is the device name listed in this FDA 510(k) record. The listed applicant is Vision Science Co., Ltd.. It received FDA 510(k) clearance on 2016-08-26 under 510(k) number K161124. 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 EYEREVE (hioxifilcon D) Soft (hydrophilic) Contact Lens for Daily Wear?

EYEREVE (hioxifilcon D) Soft (hydrophilic) Contact Lens for Daily Wear is a medical device that received FDA 510(k) clearance on 2016-08-26. The listed applicant is Vision Science Co., Ltd.. The 510(k) number is K161124.

When did EYEREVE (hioxifilcon D) Soft (hydrophilic) Contact Lens for Daily Wear receive FDA 510(k) clearance?

EYEREVE (hioxifilcon D) Soft (hydrophilic) Contact Lens for Daily Wear received FDA 510(k) clearance on 2016-08-26, under 510(k) number K161124.

Who is the listed applicant for EYEREVE (hioxifilcon D) Soft (hydrophilic) Contact Lens for Daily Wear?

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

What is the FDA product code for EYEREVE (hioxifilcon D) Soft (hydrophilic) Contact Lens for Daily Wear?

The FDA product code for EYEREVE (hioxifilcon D) Soft (hydrophilic) Contact Lens for Daily Wear is LPL.

관련 임상시험

관련 기록은 이름, 제품 코드 또는 기타 메타데이터를 사용하여 자동으로 매칭됩니다. 매칭은 검증된 임상, 과학, 기업 또는 규제 상의 관계를 입증하지 않으며, 연결된 공식 출처를 검토하시기 바랍니다.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751의료 기기 인공지능 보조 유로-캠 캐터터 평가 시스템:膀胱癌 진단을 위한NOT_YET_RECRUITING

관련 기기 (코드: LPL)

관련 기록은 이름, 제품 코드 또는 기타 메타데이터를 사용하여 자동으로 매칭됩니다. 매칭은 검증된 임상, 과학, 기업 또는 규제 상의 관계를 입증하지 않으며, 연결된 공식 출처를 검토하시기 바랍니다.

K262495Miru 1day UpSide (midafilcon A)Menicon Co, Ltd.K260507Interojo 45 (inofilcon A) Soft (Hydrophilic) Silicone Hydrogel Contact Lens with GrabSoo PlusINTEROJO, Inc.K253352Pegavision (Polymacon) Daily Disposable Soft (Hydrophilic) Contact Lenses; Pegavision (Polymacon) Soft (Hydrophilic) Contact Lenses; Pegavision (Polymacon) Color Daily Disposable Soft (Hydrophilic) Contact Lenses; Pegavision (Polymacon) Color Soft (Hydrophilic) Contact LensesPegavision CorporationK261299Pegavision (Toufilcon B) Daily Disposable Soft (Hydrophilic) Contact Lenses; Pegavision (Toufilcon B) Soft (Hydrophilic) Contact LensesPegavision CorporationK253885PUSCON WATER BALANCE-1DAY TINT (omafilcon A) SOFT (HYDROPHILIC) CONTACT LENS; PUSCON WATER BALANCE-1DAY COLOR (omafilcon A) SOFT (HYDROPHILIC) CONTACT LENSESGEO MEDICAL CO., LTD.K254269Saview SH Optic 38 UV (Senofilcon A) Visibility Tinted Soft (Hydrophilic) Contact Lens; Saview SH Optic 38 UV toric (Senofilcon A) Visibility Tinted Soft (Hydrophilic) Contact Lens; Saview SH Optic 38 UV multifocal (Senofilcon A) Visibility Tinted Soft (Hydrophilic) Contact LensSt. shine Optical Co., Ltd.

공식 출처

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