FDA 510(k)

Aveo 1-DAY Aspheric Soft Contact Lens (omafilcon A)

Número K: K162223 · 2017-01-04

Data da decisão2017-01-04

Código do produtoLPL

Comité consultivoOP

DecisãoSubstantially Equivalent

Resumo do dispositivo

Aveo 1-DAY Aspheric Soft Contact Lens (omafilcon A) is the device name listed in this FDA 510(k) record. The listed applicant is Supervision Optimax Sdn Bhd. It received FDA 510(k) clearance on 2017-01-04 under 510(k) number K162223. 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 Aveo 1-DAY Aspheric Soft Contact Lens (omafilcon A)?

Aveo 1-DAY Aspheric Soft Contact Lens (omafilcon A) is a medical device that received FDA 510(k) clearance on 2017-01-04. The listed applicant is Supervision Optimax Sdn Bhd. The 510(k) number is K162223.

When did Aveo 1-DAY Aspheric Soft Contact Lens (omafilcon A) receive FDA 510(k) clearance?

Aveo 1-DAY Aspheric Soft Contact Lens (omafilcon A) received FDA 510(k) clearance on 2017-01-04, under 510(k) number K162223.

Who is the listed applicant for Aveo 1-DAY Aspheric Soft Contact Lens (omafilcon A)?

The FDA 510(k) record lists Supervision Optimax Sdn Bhd as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Aveo 1-DAY Aspheric Soft Contact Lens (omafilcon A)?

The FDA product code for Aveo 1-DAY Aspheric Soft Contact Lens (omafilcon A) is LPL.

Ensaios clínicos relacionados

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Outros registros que listam Supervision Optimax Sdn Bhd como candidato(a)

K180985Aveo (omafilcon A) Soft (Hydrophilic) Contact Lenses

Dispositivos Relacionados (Código: LPL)

Fonte oficial

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