FDA 510(k)

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

K-번호: K231997 · 2024-10-15

결정일2024-10-15

제품 코드ILY

자문 위원회PM

결정Substantially Equivalent

기기 요약

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.

자주 묻는 질문

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

기기 요약

자주 묻는 질문

관련 임상시험

관련 기기 (코드: ILY)

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