FDA 510(k)

VueSonic One 컨택렌즈 청소 시스템, VueSonic Advance 2 컨택렌즈 청소 시스템

K-번호: K210300 · 2021-04-01

결정일2021-04-01

제품 코드LYL

자문 위원회의료장비 규제 텍스트 번역 OP

결정대체적으로 동일

기기 요약

VueSonic One Contact Lens Cleaning System, VueSonic Advance 2 Contact Lens Cleaning System is the device name listed in this FDA 510(k) record. The listed applicant is Vuesonic, LLC. It received FDA 510(k) clearance on 2021-04-01 under 510(k) number K210300. The device is classified under product code LYL. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

자주 묻는 질문

What is the VueSonic One Contact Lens Cleaning System, VueSonic Advance 2 Contact Lens Cleaning System?

VueSonic One Contact Lens Cleaning System, VueSonic Advance 2 Contact Lens Cleaning System is a medical device that received FDA 510(k) clearance on 2021-04-01. The listed applicant is Vuesonic, LLC. The 510(k) number is K210300.

When did VueSonic One Contact Lens Cleaning System, VueSonic Advance 2 Contact Lens Cleaning System receive FDA 510(k) clearance?

VueSonic One Contact Lens Cleaning System, VueSonic Advance 2 Contact Lens Cleaning System received FDA 510(k) clearance on 2021-04-01, under 510(k) number K210300.

Who is the listed applicant for VueSonic One Contact Lens Cleaning System, VueSonic Advance 2 Contact Lens Cleaning System?

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

What is the FDA product code for VueSonic One Contact Lens Cleaning System, VueSonic Advance 2 Contact Lens Cleaning System?

The FDA product code for VueSonic One Contact Lens Cleaning System, VueSonic Advance 2 Contact Lens Cleaning System is LYL.

공식 출처

FDA 데이터베이스에서 보기 →

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

VueSonic One 컨택렌즈 청소 시스템, VueSonic Advance 2 컨택렌즈 청소 시스템

기기 요약

자주 묻는 질문

관련 임상시험

관련 기기 (코드: LYL)

공식 출처