AF Laser
K-Number: K221363 · 2022-07-20
ApplicantShenB Co., Ltd.
Decision Date2022-07-20
Product CodePDZ
Advisory CommitteeSU
DecisionSubstantially Equivalent
Device Summary
AF Laser is a medical device manufactured by ShenB Co., Ltd.. It received FDA 510(k) clearance on 2022-07-20 under approval 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. It is manufactured by ShenB Co., Ltd.. The 510(k) number is K221363.
When was AF Laser approved by the FDA?
AF Laser received FDA 510(k) clearance on 2022-07-20, under approval number K221363.
What company makes AF Laser?
AF Laser is manufactured by ShenB Co., Ltd..
What is the FDA product code for AF Laser?
The FDA product code for AF Laser is PDZ.
Other Devices by ShenB Co., Ltd.
Related Devices (Code: PDZ)
Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.