FDA 510(k)

AF Laser

K-Number: K221363 · 2022-07-20

Decision Date2022-07-20

Product CodePDZ

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

AF Laser is the device name listed in this FDA 510(k) record. The listed applicant is ShenB Co., Ltd.. It received FDA 510(k) clearance on 2022-07-20 under 510(k) number K221363. The device is classified under product code PDZ. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AF Laser?

AF Laser is a medical device that received FDA 510(k) clearance on 2022-07-20. The listed applicant is ShenB Co., Ltd.. The 510(k) number is K221363.

When did AF Laser receive FDA 510(k) clearance?

AF Laser received FDA 510(k) clearance on 2022-07-20, under 510(k) number K221363.

Who is the listed applicant for AF Laser?

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

What is the FDA product code for AF Laser?

The FDA product code for AF Laser is PDZ.

Other records listing ShenB Co., Ltd. as applicant

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.