FDA 510(k)

Appareil de photothérapie à excimère de 308 nm (CN-308E, KN-4003B3, KN-4003B4, KN-5000C KN-5000D, KN-5000H, KN-5000K)

Numéro K : K242977 · 2025-02-06

DemandeurXuzhou Kernel Medical Equipment Co., Ltd.

Date de décision2025-02-06

Code produitFTC

Comité consultatifSU

DécisionSubstantially Equivalent

Résumé du dispositif

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

Questions fréquentes

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. The listed applicant is Xuzhou Kernel Medical Equipment Co., Ltd.. The 510(k) number is K242977.

When did 308nm Excimer Phototherapy Device (CN-308E, KN-4003B3, KN-4003B4, KN-5000C KN-5000D, KN-5000H, KN-5000K) receive FDA 510(k) clearance?

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 510(k) number K242977.

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

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

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.

Essais cliniques associés

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Autres dossiers indiquant Xuzhou Kernel Medical Equipment Co., Ltd. en tant que demandeur

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Dispositifs connexes (Code : FTC)

K254234Phototherapy System (DUV-COMBO)Choyang Medics Co., Ltd.K253871Klär Lite (RCW-KL1000)Radcliffe Watts, LLC K250425Ultraviolet Phototherapy DeviceAPK Technology Co., Ltd.K244022Système de photothérapie UV à 308 nm (UV-K); Système de photothérapie UV à 308 nm (UV-X); Système de photothérapie UV à 308 nm (UV-Y); Système de photothérapie UV à 308 nm (UV-Z)Boston Aesthetics, Inc.K242908UV Phototherapy Device (Group A: SQ308PCHFD, SQ308PCQFD, SQ308PCPFD, SQ308PCNFD, SQ308PCMFD); UV Phototherapy Device (Group B: SQ308PHTFF, SQ308PHSFF, SQ308PHRFF, SQ308PHZFG, SQ308PPUFF, SQ308PPVFF, SQ308PPWFG)Shanghai Sigma High-Tech Co., Ltd.K233811DT Controlled Phototherapy EquipmentDaavlin Distributing Co.

Source officielle

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