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FDA 510(k)

Fiber Laser Treatment System

K-Number: K221770 · 2022-10-13

Decision Date2022-10-13
Product CodeONG
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Fiber Laser Treatment System is a medical device manufactured by Shanghai Apolo Medical Technology Co., Ltd.. It received FDA 510(k) clearance on 2022-10-13 under approval number K221770. The device is classified under product code ONG. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Fiber Laser Treatment System?

Fiber Laser Treatment System is a medical device that received FDA 510(k) clearance on 2022-10-13. It is manufactured by Shanghai Apolo Medical Technology Co., Ltd.. The 510(k) number is K221770.

When was Fiber Laser Treatment System approved by the FDA?

Fiber Laser Treatment System received FDA 510(k) clearance on 2022-10-13, under approval number K221770.

What company makes Fiber Laser Treatment System?

Fiber Laser Treatment System is manufactured by Shanghai Apolo Medical Technology Co., Ltd..

What is the FDA product code for Fiber Laser Treatment System?

The FDA product code for Fiber Laser Treatment System is ONG.

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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.