FDA 510(k)

プライモデンタルレーザー（プライモ、プライモコムフォート、プライモライト、プライモブルー、およびプライモトリプロ）

K番号: K232222 · 2023-11-27

決定日2023-11-27

製品コードNVK

諮問委員会SU （以下のテキストは翻訳されていません。） Policy: medical-regulatory-v1

決定大幅同等

医療機器の概要

Primo Dental Laser (Primo, Primo Komfort, Primo Lite, Primo Blue, and Primo Triplo) is the device name listed in this FDA 510(k) record. The listed applicant is Medency S.R.L.. It received FDA 510(k) clearance on 2023-11-27 under 510(k) number K232222. The device is classified under product code NVK. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

よくある質問

What is the Primo Dental Laser (Primo, Primo Komfort, Primo Lite, Primo Blue, and Primo Triplo)?

Primo Dental Laser (Primo, Primo Komfort, Primo Lite, Primo Blue, and Primo Triplo) is a medical device that received FDA 510(k) clearance on 2023-11-27. The listed applicant is Medency S.R.L.. The 510(k) number is K232222.

When did Primo Dental Laser (Primo, Primo Komfort, Primo Lite, Primo Blue, and Primo Triplo) receive FDA 510(k) clearance?

Primo Dental Laser (Primo, Primo Komfort, Primo Lite, Primo Blue, and Primo Triplo) received FDA 510(k) clearance on 2023-11-27, under 510(k) number K232222.

Who is the listed applicant for Primo Dental Laser (Primo, Primo Komfort, Primo Lite, Primo Blue, and Primo Triplo)?

The FDA 510(k) record lists Medency S.R.L. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Primo Dental Laser (Primo, Primo Komfort, Primo Lite, Primo Blue, and Primo Triplo)?

The FDA product code for Primo Dental Laser (Primo, Primo Komfort, Primo Lite, Primo Blue, and Primo Triplo) is NVK.

申請者としてMedency S.R.L.を記載するその他の記録

K240543ラピドメディカルレーザー（ラピドMED、ラピドデルマ、ラピドENT、ラピドポディア）

公式ソース

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