FDA 510(k)

사용자 정의 고정된 기능성 기능성 스크렐라 contact 렌즈

K-번호: K213880 · 2022-01-07

결정일2022-01-07

제품 코드HQD

자문 위원회OP

결정Substantially Equivalent

기기 요약

Custom Stable Rigid Gas Permeable Scleral Contact Lens is the device name listed in this FDA 510(k) record. The listed applicant is Valley Contax, Inc.. It received FDA 510(k) clearance on 2022-01-07 under 510(k) number K213880. The device is classified under product code HQD. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

자주 묻는 질문

What is the Custom Stable Rigid Gas Permeable Scleral Contact Lens?

Custom Stable Rigid Gas Permeable Scleral Contact Lens is a medical device that received FDA 510(k) clearance on 2022-01-07. The listed applicant is Valley Contax, Inc.. The 510(k) number is K213880.

When did Custom Stable Rigid Gas Permeable Scleral Contact Lens receive FDA 510(k) clearance?

Custom Stable Rigid Gas Permeable Scleral Contact Lens received FDA 510(k) clearance on 2022-01-07, under 510(k) number K213880.

Who is the listed applicant for Custom Stable Rigid Gas Permeable Scleral Contact Lens?

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

What is the FDA product code for Custom Stable Rigid Gas Permeable Scleral Contact Lens?

The FDA product code for Custom Stable Rigid Gas Permeable Scleral Contact Lens is HQD.

Valley Contax, Inc.를 신청인으로 등재한 기타 기록

K202860Valley Contax Single Vision (SV) Gas Permeable Contact Lens (roflufocon D, roflufocon E, tisilfocon A, hexafocon A, enflufocon A), Valley Contax Goldeneye Aspheric Front Multifocal (AFM) Gas Permeable Contact Lens (roflufocon D, roflufocon E, tisilfocon A, hexafocon A, enflufocon A), Valley Contax V Kone (VK) Gas Permeable Contact Lens (roflufocon D, roflufocon E, tisilfocon A, hexafocon A, enflufocon A)K170335커스텀 스탬블™ 고정형 가스투과성 스크렐라 contact 렌즈

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