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FDA 510(k)

Skylit Phototherapy System

K-Number: K170489 · 2017-05-23

ApplicantSkylit Medical
Decision Date2017-05-23
Product CodeFTC
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Skylit Phototherapy System is the device name listed in this FDA 510(k) record. The listed applicant is Skylit Medical. It received FDA 510(k) clearance on 2017-05-23 under 510(k) number K170489. 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 Skylit Phototherapy System?

Skylit Phototherapy System is a medical device that received FDA 510(k) clearance on 2017-05-23. The listed applicant is Skylit Medical. The 510(k) number is K170489.

When did Skylit Phototherapy System receive FDA 510(k) clearance?

Skylit Phototherapy System received FDA 510(k) clearance on 2017-05-23, under 510(k) number K170489.

Who is the listed applicant for Skylit Phototherapy System?

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

What is the FDA product code for Skylit Phototherapy System?

The FDA product code for Skylit Phototherapy System is FTC.

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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