FDA 510(k)

HPM38 (폴리막론) 일일 착용 소프트(수용성) 컨택 렌즈 (HPM38)

K-번호: K241884 · 2025-03-20

결정일2025-03-20

제품 코드LPL

자문 위원회의료장비 규제 텍스트 번역 OP

결정대체적으로 동일

기기 요약

HPM38 (polymacon) Daily Wear Soft (hydrophilic) Contact Lens (HPM38) is the device name listed in this FDA 510(k) record. The listed applicant is Hunan Haipuming Technology Co., Ltd.. It received FDA 510(k) clearance on 2025-03-20 under 510(k) number K241884. 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 HPM38 (polymacon) Daily Wear Soft (hydrophilic) Contact Lens (HPM38)?

HPM38 (polymacon) Daily Wear Soft (hydrophilic) Contact Lens (HPM38) is a medical device that received FDA 510(k) clearance on 2025-03-20. The listed applicant is Hunan Haipuming Technology Co., Ltd.. The 510(k) number is K241884.

When did HPM38 (polymacon) Daily Wear Soft (hydrophilic) Contact Lens (HPM38) receive FDA 510(k) clearance?

HPM38 (polymacon) Daily Wear Soft (hydrophilic) Contact Lens (HPM38) received FDA 510(k) clearance on 2025-03-20, under 510(k) number K241884.

Who is the listed applicant for HPM38 (polymacon) Daily Wear Soft (hydrophilic) Contact Lens (HPM38)?

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

What is the FDA product code for HPM38 (polymacon) Daily Wear Soft (hydrophilic) Contact Lens (HPM38)?

The FDA product code for HPM38 (polymacon) Daily Wear Soft (hydrophilic) Contact Lens (HPM38) is LPL.

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

HPM38 (폴리막론) 일일 착용 소프트(수용성) 컨택 렌즈 (HPM38)

기기 요약

자주 묻는 질문

관련 임상시험

관련 기기 (코드: LPL)

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