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FDA 510(k)

Painless IPL System - KDT750

K-Number: K220214 · 2023-02-18

ApplicantShanghai Omni Laser Skinology Co., Ltd.
Decision Date2023-02-18
Product CodeONF
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Painless IPL System - KDT750 is a medical device manufactured by Shanghai Omni Laser Skinology Co., Ltd.. It received FDA 510(k) clearance on 2023-02-18 under approval number K220214. The device is classified under product code ONF. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Painless IPL System - KDT750?

Painless IPL System - KDT750 is a medical device that received FDA 510(k) clearance on 2023-02-18. It is manufactured by Shanghai Omni Laser Skinology Co., Ltd.. The 510(k) number is K220214.

When was Painless IPL System - KDT750 approved by the FDA?

Painless IPL System - KDT750 received FDA 510(k) clearance on 2023-02-18, under approval number K220214.

What company makes Painless IPL System - KDT750?

Painless IPL System - KDT750 is manufactured by Shanghai Omni Laser Skinology Co., Ltd..

What is the FDA product code for Painless IPL System - KDT750?

The FDA product code for Painless IPL System - KDT750 is ONF.

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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.

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