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FDA 510(k)

RESOLVE UVB PHOTOTHERAPY SYSTEM

K-Number: K072035 · 2007-10-16

ApplicantAllux Medical
Decision Date2007-10-16
Product CodeFTC
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

RESOLVE UVB PHOTOTHERAPY SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Allux Medical. It received FDA 510(k) clearance on 2007-10-16 under 510(k) number K072035. 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 RESOLVE UVB PHOTOTHERAPY SYSTEM?

RESOLVE UVB PHOTOTHERAPY SYSTEM is a medical device that received FDA 510(k) clearance on 2007-10-16. The listed applicant is Allux Medical. The 510(k) number is K072035.

When did RESOLVE UVB PHOTOTHERAPY SYSTEM receive FDA 510(k) clearance?

RESOLVE UVB PHOTOTHERAPY SYSTEM received FDA 510(k) clearance on 2007-10-16, under 510(k) number K072035.

Who is the listed applicant for RESOLVE UVB PHOTOTHERAPY SYSTEM?

The FDA 510(k) record lists Allux Medical as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for RESOLVE UVB PHOTOTHERAPY SYSTEM?

The FDA product code for RESOLVE UVB PHOTOTHERAPY SYSTEM is FTC.

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Related Devices (Code: FTC)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K254234Phototherapy System (DUV-COMBO)Choyang Medics Co., Ltd.K253871Klär Lite (RCW-KL1000)Radcliffe Watts, LLCK250425Ultraviolet Phototherapy DeviceAPK Technology Co., Ltd.K244022308nm UV Phototherapy System (UV-K); 308nm UV Phototherapy System (UV-X); 308nm UV Phototherapy System (UV-Y); 308nm UV Phototherapy System (UV-Z)Boston Aesthetics, Inc.K242977308nm Excimer Phototherapy Device (CN-308E, KN-4003B3, KN-4003B4, KN-5000C KN-5000D, KN-5000H, KN-5000K)Xuzhou Kernel Medical Equipment Co., Ltd.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.

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.

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