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FDA 510(k)

THERALIGHT UV120-2 UVA/UVB PHOTOTHERAPY SYSTEM

K-Number: K024020 · 2003-01-17

ApplicantTheralight, Inc.
Decision Date2003-01-17
Product CodeFTC
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

THERALIGHT UV120-2 UVA/UVB PHOTOTHERAPY SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Theralight, Inc.. It received FDA 510(k) clearance on 2003-01-17 under 510(k) number K024020. 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 THERALIGHT UV120-2 UVA/UVB PHOTOTHERAPY SYSTEM?

THERALIGHT UV120-2 UVA/UVB PHOTOTHERAPY SYSTEM is a medical device that received FDA 510(k) clearance on 2003-01-17. The listed applicant is Theralight, Inc.. The 510(k) number is K024020.

When did THERALIGHT UV120-2 UVA/UVB PHOTOTHERAPY SYSTEM receive FDA 510(k) clearance?

THERALIGHT UV120-2 UVA/UVB PHOTOTHERAPY SYSTEM received FDA 510(k) clearance on 2003-01-17, under 510(k) number K024020.

Who is the listed applicant for THERALIGHT UV120-2 UVA/UVB PHOTOTHERAPY SYSTEM?

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

What is the FDA product code for THERALIGHT UV120-2 UVA/UVB PHOTOTHERAPY SYSTEM?

The FDA product code for THERALIGHT UV120-2 UVA/UVB PHOTOTHERAPY SYSTEM is FTC.

Related Clinical Trials

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Other records listing Theralight, 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.

K061295VERSACLEAR SKIN THERAPY SYSTEM, MODEL 100K051259VERSACLEAR SKIN THERAPY SYSTEM, MODEL 100K022165THERALIGHT UV120-2 UVA/UVB PHOTOTHERAPY SYSTEM, MODEL UV120-2

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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