FDA 510(k)

ADORE (polymacon) Daily Wear Soft (hydrofilic) Contact Lenses (Tinted/color)

Número K: K181656 · 2019-03-05

Data da decisão2019-03-05

Código do produtoLPL

Comité consultivoOP

DecisãoSubstantially Equivalent

Resumo do dispositivo

ADORE (polymacon) Daily Wear Soft (hydrophilic) Contact Lenses (Tinted/color) is the device name listed in this FDA 510(k) record. The listed applicant is Eyemed Technologies S.R.L.. It received FDA 510(k) clearance on 2019-03-05 under 510(k) number K181656. The device is classified under product code LPL. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the ADORE (polymacon) Daily Wear Soft (hydrophilic) Contact Lenses (Tinted/color)?

ADORE (polymacon) Daily Wear Soft (hydrophilic) Contact Lenses (Tinted/color) is a medical device that received FDA 510(k) clearance on 2019-03-05. The listed applicant is Eyemed Technologies S.R.L.. The 510(k) number is K181656.

When did ADORE (polymacon) Daily Wear Soft (hydrophilic) Contact Lenses (Tinted/color) receive FDA 510(k) clearance?

ADORE (polymacon) Daily Wear Soft (hydrophilic) Contact Lenses (Tinted/color) received FDA 510(k) clearance on 2019-03-05, under 510(k) number K181656.

Who is the listed applicant for ADORE (polymacon) Daily Wear Soft (hydrophilic) Contact Lenses (Tinted/color)?

The FDA 510(k) record lists Eyemed Technologies S.R.L. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ADORE (polymacon) Daily Wear Soft (hydrophilic) Contact Lenses (Tinted/color)?

The FDA product code for ADORE (polymacon) Daily Wear Soft (hydrophilic) Contact Lenses (Tinted/color) is LPL.

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Dispositivos Relacionados (Código: LPL)

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