FDA 510(k)

P-CON (폴리막론) 소프트(수용성) 컨택렌즈 (침색, 컬러)

K-번호: K242855 · 2025-07-30

결정일2025-07-30

제품 코드LPL

자문 위원회의료장비 규제 텍스트 번역 OP

결정대체적으로 동일

기기 요약

P-CON (polymacon) Soft (hydrophilic) Contact Lenses (Tinted, Color) is the device name listed in this FDA 510(k) record. The listed applicant is E.O.S Co., Ltd.. It received FDA 510(k) clearance on 2025-07-30 under 510(k) number K242855. 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 P-CON (polymacon) Soft (hydrophilic) Contact Lenses (Tinted, Color)?

P-CON (polymacon) Soft (hydrophilic) Contact Lenses (Tinted, Color) is a medical device that received FDA 510(k) clearance on 2025-07-30. The listed applicant is E.O.S Co., Ltd.. The 510(k) number is K242855.

When did P-CON (polymacon) Soft (hydrophilic) Contact Lenses (Tinted, Color) receive FDA 510(k) clearance?

P-CON (polymacon) Soft (hydrophilic) Contact Lenses (Tinted, Color) received FDA 510(k) clearance on 2025-07-30, under 510(k) number K242855.

Who is the listed applicant for P-CON (polymacon) Soft (hydrophilic) Contact Lenses (Tinted, Color)?

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

What is the FDA product code for P-CON (polymacon) Soft (hydrophilic) Contact Lenses (Tinted, Color)?

The FDA product code for P-CON (polymacon) Soft (hydrophilic) Contact Lenses (Tinted, Color) is LPL.

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P-CON (폴리막론) 소프트(수용성) 컨택렌즈 (침색, 컬러)

기기 요약

자주 묻는 질문

관련 임상시험

관련 기기 (코드: LPL)

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