FDA 510(k)

Desio (hioxifilcon D) Daily Wear Soft (hydrophilic) Contact Lenses (Clear and Tinted)

K-Nummer: K181050 · 2018-06-13

Entscheidungsdatum2018-06-13

ProduktcodeLPL

BeratungsausschussOP

EntscheidungSubstantially Equivalent

Produktübersicht

Desio (hioxifilcon D) Daily Wear Soft (hydrophilic) Contact Lenses (Clear and Tinted) is the device name listed in this FDA 510(k) record. The listed applicant is Qualimed Srl. It received FDA 510(k) clearance on 2018-06-13 under 510(k) number K181050. The device is classified under product code LPL. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Häufig gestellte Fragen

What is the Desio (hioxifilcon D) Daily Wear Soft (hydrophilic) Contact Lenses (Clear and Tinted)?

Desio (hioxifilcon D) Daily Wear Soft (hydrophilic) Contact Lenses (Clear and Tinted) is a medical device that received FDA 510(k) clearance on 2018-06-13. The listed applicant is Qualimed Srl. The 510(k) number is K181050.

When did Desio (hioxifilcon D) Daily Wear Soft (hydrophilic) Contact Lenses (Clear and Tinted) receive FDA 510(k) clearance?

Desio (hioxifilcon D) Daily Wear Soft (hydrophilic) Contact Lenses (Clear and Tinted) received FDA 510(k) clearance on 2018-06-13, under 510(k) number K181050.

Who is the listed applicant for Desio (hioxifilcon D) Daily Wear Soft (hydrophilic) Contact Lenses (Clear and Tinted)?

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

What is the FDA product code for Desio (hioxifilcon D) Daily Wear Soft (hydrophilic) Contact Lenses (Clear and Tinted)?

The FDA product code for Desio (hioxifilcon D) Daily Wear Soft (hydrophilic) Contact Lenses (Clear and Tinted) is LPL.

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Verwandte Geräte (Code: LPL)

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