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FDA 510(k)

SIRONA 100 Therapy Laser System (OEM's Model EVANLAS)

Número K: K231997 · 2024-10-15

RequerenteCure Point Therapeutics, Inc.
Data da decisão2024-10-15
Código do produtoILY
Comité consultivoPM
DecisãoSubstantially Equivalent

Resumo do dispositivo

SIRONA 100 Therapy Laser System (OEM's Model EVANLAS) is the device name listed in this FDA 510(k) record. The listed applicant is Cure Point Therapeutics, Inc.. It received FDA 510(k) clearance on 2024-10-15 under 510(k) number K231997. The device is classified under product code ILY. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the SIRONA 100 Therapy Laser System (OEM's Model EVANLAS)?

SIRONA 100 Therapy Laser System (OEM's Model EVANLAS) is a medical device that received FDA 510(k) clearance on 2024-10-15. The listed applicant is Cure Point Therapeutics, Inc.. The 510(k) number is K231997.

When did SIRONA 100 Therapy Laser System (OEM's Model EVANLAS) receive FDA 510(k) clearance?

SIRONA 100 Therapy Laser System (OEM's Model EVANLAS) received FDA 510(k) clearance on 2024-10-15, under 510(k) number K231997.

Who is the listed applicant for SIRONA 100 Therapy Laser System (OEM's Model EVANLAS)?

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

What is the FDA product code for SIRONA 100 Therapy Laser System (OEM's Model EVANLAS)?

The FDA product code for SIRONA 100 Therapy Laser System (OEM's Model EVANLAS) is ILY.

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Dispositivos Relacionados (Código: ILY)

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Fonte oficial

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