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)

Softcure 96

K-Number: K170068 · 2017-05-05

ApplicantWellray Medical Laser, Inc.
Decision Date2017-05-05
Product CodeILY
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

Softcure 96 is a medical device manufactured by Wellray Medical Laser, Inc.. It received FDA 510(k) clearance on 2017-05-05 under approval number K170068. The device is classified under product code ILY. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Softcure 96?

Softcure 96 is a medical device that received FDA 510(k) clearance on 2017-05-05. It is manufactured by Wellray Medical Laser, Inc.. The 510(k) number is K170068.

When was Softcure 96 approved by the FDA?

Softcure 96 received FDA 510(k) clearance on 2017-05-05, under approval number K170068.

What company makes Softcure 96?

Softcure 96 is manufactured by Wellray Medical Laser, Inc..

What is the FDA product code for Softcure 96?

The FDA product code for Softcure 96 is ILY.

Related Devices (Code: ILY)

K160849WS(TM) Far-Infrared Therapy Unit, Model KP-B210Ws Far IR Medical Technology Co., Ltd. K152087HeatLux Pro IIHome Skinovations , Ltd. K161198Lumix Ultra 1, Lumix Ultra 2, Lumix Ultra 3Usa Laser Biotech, Inc. K152461The Time Machine Series LasersMedical Lasers Manufacturer, Inc. K153399LightStim Professional LED BedLed Intellectual Properties, LLC K160947LUMIX CPS 1 IR Lamp System LUMIX CPS 2 IR Lamp System LUMIX CPS 3 IR Lamp System LUMIX CPS 4 IR Lamp System LUMIX CPS 5 IR Lamp SystemUsa Laser Biotech, Inc.

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.

↑