Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

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 a medical device manufactured by Skylit Medical. It received FDA 510(k) clearance on 2017-05-23 under approval 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. It is manufactured by Skylit Medical. The 510(k) number is K170489.

When was Skylit Phototherapy System approved by the FDA?

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

What company makes Skylit Phototherapy System?

Skylit Phototherapy System is manufactured by Skylit Medical.

What is the FDA product code for Skylit Phototherapy System?

The FDA product code for Skylit Phototherapy System is FTC.

Related Devices (Code: FTC)

K1537493 Series Phototherapy UnitDaavlin Distributing Company K171702Exciplex308nmClarteis K182215ClearLink Controlled Phototherapy EquipmentDaavlin Distributing Company K172273308nm Excimer SystemChongqing Peninsula Medical Technology Co., Ltd. K173436Luma Light SystemLuma Therapeutics K191086ExciplexClarteis

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

↑