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FDA 510(k)

ML24000 UVA-1 PHOTOTHERAPY UNIT

K-Number: K103708 · 2011-02-22

ApplicantThe Daavlin Distributing Company
Decision Date2011-02-22
Product CodeFTC
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

ML24000 UVA-1 PHOTOTHERAPY UNIT is the device name listed in this FDA 510(k) record. The listed applicant is The Daavlin Distributing Company. It received FDA 510(k) clearance on 2011-02-22 under 510(k) number K103708. 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 ML24000 UVA-1 PHOTOTHERAPY UNIT?

ML24000 UVA-1 PHOTOTHERAPY UNIT is a medical device that received FDA 510(k) clearance on 2011-02-22. The listed applicant is The Daavlin Distributing Company. The 510(k) number is K103708.

When did ML24000 UVA-1 PHOTOTHERAPY UNIT receive FDA 510(k) clearance?

ML24000 UVA-1 PHOTOTHERAPY UNIT received FDA 510(k) clearance on 2011-02-22, under 510(k) number K103708.

Who is the listed applicant for ML24000 UVA-1 PHOTOTHERAPY UNIT?

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

What is the FDA product code for ML24000 UVA-1 PHOTOTHERAPY UNIT?

The FDA product code for ML24000 UVA-1 PHOTOTHERAPY UNIT 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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