FDA 510(k)

フレックスレンズシリコンハイドロゲルデイリー装用ソフト（水溶性）コンタクトレンズ（エフロフィルコンA）

K番号: K242059 · 2024-08-14

申請者X-Cel Specialty Contacts, A Walman Optical Company

決定日2024-08-14

製品コードLPL

諮問委員会OP

決定Substantially Equivalent

医療機器の概要

Flexlens Silicone Hydrogel Daily Wear Soft (Hydrophilic) Contact Lens (efrofilcon A) is the device name listed in this FDA 510(k) record. The listed applicant is X-Cel Specialty Contacts, A Walman Optical Company. It received FDA 510(k) clearance on 2024-08-14 under 510(k) number K242059. The device is classified under product code LPL. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

よくある質問

What is the Flexlens Silicone Hydrogel Daily Wear Soft (Hydrophilic) Contact Lens (efrofilcon A)?

Flexlens Silicone Hydrogel Daily Wear Soft (Hydrophilic) Contact Lens (efrofilcon A) is a medical device that received FDA 510(k) clearance on 2024-08-14. The listed applicant is X-Cel Specialty Contacts, A Walman Optical Company. The 510(k) number is K242059.

When did Flexlens Silicone Hydrogel Daily Wear Soft (Hydrophilic) Contact Lens (efrofilcon A) receive FDA 510(k) clearance?

Flexlens Silicone Hydrogel Daily Wear Soft (Hydrophilic) Contact Lens (efrofilcon A) received FDA 510(k) clearance on 2024-08-14, under 510(k) number K242059.

Who is the listed applicant for Flexlens Silicone Hydrogel Daily Wear Soft (Hydrophilic) Contact Lens (efrofilcon A)?

The FDA 510(k) record lists X-Cel Specialty Contacts, A Walman Optical Company as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Flexlens Silicone Hydrogel Daily Wear Soft (Hydrophilic) Contact Lens (efrofilcon A)?

The FDA product code for Flexlens Silicone Hydrogel Daily Wear Soft (Hydrophilic) Contact Lens (efrofilcon A) is LPL.

関連機器（コード：LPL）

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医療機器の概要

よくある質問

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関連機器（コード：LPL）

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