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FDA 510(k)

LEVIA PHOTOTHERAPY SYSTEM

K-Number: K040062 · 2004-02-13

ApplicantLerner Medical Devices, Inc.
Decision Date2004-02-13
Product CodeFTC
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

LEVIA PHOTOTHERAPY SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Lerner Medical Devices, Inc.. It received FDA 510(k) clearance on 2004-02-13 under 510(k) number K040062. 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 LEVIA PHOTOTHERAPY SYSTEM?

LEVIA PHOTOTHERAPY SYSTEM is a medical device that received FDA 510(k) clearance on 2004-02-13. The listed applicant is Lerner Medical Devices, Inc.. The 510(k) number is K040062.

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

LEVIA PHOTOTHERAPY SYSTEM received FDA 510(k) clearance on 2004-02-13, under 510(k) number K040062.

Who is the listed applicant for LEVIA PHOTOTHERAPY SYSTEM?

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

What is the FDA product code for LEVIA PHOTOTHERAPY SYSTEM?

The FDA product code for LEVIA PHOTOTHERAPY SYSTEM is FTC.

Related Clinical Trials

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.

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Other records listing Lerner Medical Devices, Inc. as applicant

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.

K091568LH-75 PHOTOTHERAPY SYSTEMK090097LH-75T PHOTOTHERAPY SYSTEM

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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