FDA 510(k)

Samfilcon B Custom Contact Lens

Número K: K230954 · 2023-11-17

Data da decisão2023-11-17

Código do produtoLPL

Comité consultivoOP

DecisãoSubstantially Equivalent

Resumo do dispositivo

Samfilcon B Custom Contact Lens is the device name listed in this FDA 510(k) record. The listed applicant is Bausch + Lomb, Incorporated. It received FDA 510(k) clearance on 2023-11-17 under 510(k) number K230954. 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 Samfilcon B Custom Contact Lens?

Samfilcon B Custom Contact Lens is a medical device that received FDA 510(k) clearance on 2023-11-17. The listed applicant is Bausch + Lomb, Incorporated. The 510(k) number is K230954.

When did Samfilcon B Custom Contact Lens receive FDA 510(k) clearance?

Samfilcon B Custom Contact Lens received FDA 510(k) clearance on 2023-11-17, under 510(k) number K230954.

Who is the listed applicant for Samfilcon B Custom Contact Lens?

The FDA 510(k) record lists Bausch + Lomb, Incorporated as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Samfilcon B Custom Contact Lens?

The FDA product code for Samfilcon B Custom Contact Lens is LPL.

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Outros registros que listam Bausch + Lomb, Incorporated como candidato(a)

K211786Independent Corneal Viewing Chamber (IVC-21)K200528Bausch + Lomb (Kalifilcon A) Soft Contact Lens, Bausch + Lomb (Kalifilcon A) Soft Contact Lens for astigmatism K171404BOSTON XO (hexafocon A), BOSTON XO2 (hexafocon B)

Dispositivos Relacionados (Código: LPL)

Fonte oficial

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