FDA 510(k)

NewVision SC (tisilfocon A) Scleral Lens; NewVision SC Daily Wear Ortho-K (tisilfocon A) Corneo-Scleral Lens

Número K: K230910 · 2023-06-16

Data da decisão2023-06-16

Código do produtoHQD

Comité consultivoOP

DecisãoSubstantially Equivalent

Resumo do dispositivo

NewVision SC (tisilfocon A) Scleral Lens; NewVision SC Daily Wear Ortho-K (tisilfocon A) Corneo-Scleral Lens is the device name listed in this FDA 510(k) record. The listed applicant is Acculens, Inc.. It received FDA 510(k) clearance on 2023-06-16 under 510(k) number K230910. The device is classified under product code HQD. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the NewVision SC (tisilfocon A) Scleral Lens; NewVision SC Daily Wear Ortho-K (tisilfocon A) Corneo-Scleral Lens?

NewVision SC (tisilfocon A) Scleral Lens; NewVision SC Daily Wear Ortho-K (tisilfocon A) Corneo-Scleral Lens is a medical device that received FDA 510(k) clearance on 2023-06-16. The listed applicant is Acculens, Inc.. The 510(k) number is K230910.

When did NewVision SC (tisilfocon A) Scleral Lens; NewVision SC Daily Wear Ortho-K (tisilfocon A) Corneo-Scleral Lens receive FDA 510(k) clearance?

NewVision SC (tisilfocon A) Scleral Lens; NewVision SC Daily Wear Ortho-K (tisilfocon A) Corneo-Scleral Lens received FDA 510(k) clearance on 2023-06-16, under 510(k) number K230910.

Who is the listed applicant for NewVision SC (tisilfocon A) Scleral Lens; NewVision SC Daily Wear Ortho-K (tisilfocon A) Corneo-Scleral Lens?

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

What is the FDA product code for NewVision SC (tisilfocon A) Scleral Lens; NewVision SC Daily Wear Ortho-K (tisilfocon A) Corneo-Scleral Lens?

The FDA product code for NewVision SC (tisilfocon A) Scleral Lens; NewVision SC Daily Wear Ortho-K (tisilfocon A) Corneo-Scleral Lens is HQD.

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Fonte oficial

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