FDA 510(k)

SMART PERFORMER 55 (Ocufilcon D) Soft (hydrophilic) Contact Lens

Número K: K152657 · 2016-05-17

Data da decisão2016-05-17

Código do produtoLPL

Comité consultivoOP

DecisãoSubstantially Equivalent

Resumo do dispositivo

SMART PERFORMER 55 (Ocufilcon D) Soft (hydrophilic) Contact Lens is the device name listed in this FDA 510(k) record. The listed applicant is Smart Performer Corp. , Ltd.. It received FDA 510(k) clearance on 2016-05-17 under 510(k) number K152657. 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 SMART PERFORMER 55 (Ocufilcon D) Soft (hydrophilic) Contact Lens?

SMART PERFORMER 55 (Ocufilcon D) Soft (hydrophilic) Contact Lens is a medical device that received FDA 510(k) clearance on 2016-05-17. The listed applicant is Smart Performer Corp. , Ltd.. The 510(k) number is K152657.

When did SMART PERFORMER 55 (Ocufilcon D) Soft (hydrophilic) Contact Lens receive FDA 510(k) clearance?

SMART PERFORMER 55 (Ocufilcon D) Soft (hydrophilic) Contact Lens received FDA 510(k) clearance on 2016-05-17, under 510(k) number K152657.

Who is the listed applicant for SMART PERFORMER 55 (Ocufilcon D) Soft (hydrophilic) Contact Lens?

The FDA 510(k) record lists Smart Performer Corp. , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SMART PERFORMER 55 (Ocufilcon D) Soft (hydrophilic) Contact Lens?

The FDA product code for SMART PERFORMER 55 (Ocufilcon D) Soft (hydrophilic) Contact Lens is LPL.

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Outros registros que listam Smart Performer Corp. , Ltd. como candidato(a)

K151847SMART PERFORMER (Polymacon) Soft (Hydrophilic) Contact Lens

Dispositivos Relacionados (Código: LPL)

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