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FDA 510(k)

308nm Excimer Phototherapy Device (CN-308E, KN-4003B3, KN-4003B4, KN-5000C KN-5000D, KN-5000H, KN-5000K)

K-Number: K242977 · 2025-02-06

ApplicantXuzhou Kernel Medical Equipment Co., Ltd.
Decision Date2025-02-06
Product CodeFTC
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

308nm Excimer Phototherapy Device (CN-308E, KN-4003B3, KN-4003B4, KN-5000C KN-5000D, KN-5000H, KN-5000K) is a medical device manufactured by Xuzhou Kernel Medical Equipment Co., Ltd.. It received FDA 510(k) clearance on 2025-02-06 under approval number K242977. The device is classified under product code FTC. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the 308nm Excimer Phototherapy Device (CN-308E, KN-4003B3, KN-4003B4, KN-5000C KN-5000D, KN-5000H, KN-5000K)?

308nm Excimer Phototherapy Device (CN-308E, KN-4003B3, KN-4003B4, KN-5000C KN-5000D, KN-5000H, KN-5000K) is a medical device that received FDA 510(k) clearance on 2025-02-06. It is manufactured by Xuzhou Kernel Medical Equipment Co., Ltd.. The 510(k) number is K242977.

When was 308nm Excimer Phototherapy Device (CN-308E, KN-4003B3, KN-4003B4, KN-5000C KN-5000D, KN-5000H, KN-5000K) approved by the FDA?

308nm Excimer Phototherapy Device (CN-308E, KN-4003B3, KN-4003B4, KN-5000C KN-5000D, KN-5000H, KN-5000K) received FDA 510(k) clearance on 2025-02-06, under approval number K242977.

What company makes 308nm Excimer Phototherapy Device (CN-308E, KN-4003B3, KN-4003B4, KN-5000C KN-5000D, KN-5000H, KN-5000K)?

308nm Excimer Phototherapy Device (CN-308E, KN-4003B3, KN-4003B4, KN-5000C KN-5000D, KN-5000H, KN-5000K) is manufactured by Xuzhou Kernel Medical Equipment Co., Ltd..

What is the FDA product code for 308nm Excimer Phototherapy Device (CN-308E, KN-4003B3, KN-4003B4, KN-5000C KN-5000D, KN-5000H, KN-5000K)?

The FDA product code for 308nm Excimer Phototherapy Device (CN-308E, KN-4003B3, KN-4003B4, KN-5000C KN-5000D, KN-5000H, KN-5000K) is FTC.

Other Devices by Xuzhou Kernel Medical Equipment Co., Ltd.

K160341Colposcope System K190685Hair Growth System K181805UV Phototherapy K200971308nm Excimer System K200929Hair Growth System K222751LED Light Therapy Device, KN-7000L

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Related Devices (Code: FTC)

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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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