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FDA 510(k)

X80 / RADiant / PhotoElectric Therapy System (RADiant Aura)

K-Number: K230611 · 2023-07-13

ApplicantXstrahl, Ltd.
Decision Date2023-07-13
Product CodeJAD
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

X80 / RADiant / PhotoElectric Therapy System (RADiant Aura) is the device name listed in this FDA 510(k) record. The listed applicant is Xstrahl, Ltd.. It received FDA 510(k) clearance on 2023-07-13 under 510(k) number K230611. The device is classified under product code JAD. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the X80 / RADiant / PhotoElectric Therapy System (RADiant Aura)?

X80 / RADiant / PhotoElectric Therapy System (RADiant Aura) is a medical device that received FDA 510(k) clearance on 2023-07-13. The listed applicant is Xstrahl, Ltd.. The 510(k) number is K230611.

When did X80 / RADiant / PhotoElectric Therapy System (RADiant Aura) receive FDA 510(k) clearance?

X80 / RADiant / PhotoElectric Therapy System (RADiant Aura) received FDA 510(k) clearance on 2023-07-13, under 510(k) number K230611.

Who is the listed applicant for X80 / RADiant / PhotoElectric Therapy System (RADiant Aura)?

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

What is the FDA product code for X80 / RADiant / PhotoElectric Therapy System (RADiant Aura)?

The FDA product code for X80 / RADiant / PhotoElectric Therapy System (RADiant Aura) is JAD.

Other records listing Xstrahl, Ltd. 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.

K240671XBeam (v2)K172080Photoelectric Therapy System

Related Devices (Code: JAD)

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.

K250692GentleBeam (GB1000)Voxel Ray Solutions, LLCK241174INTRABEAM (700); And accessories (INTRABEAM SMART Stand, INTRABEAM SMART Spherical Applicator, INTRABEAM Spherical Sizer Set, INTRABEAM Needle Applicator)Carl Zeiss Meditec, AGK213942EsteyaNucletron B.V.K190255Sensus Healthcare TVM Balloon ApplicatorSensus Healthcare, Inc.K182641Sensus IORT SystemSensus Healthcare, Inc.K173425SRT-100+Sensus Healthcare, 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.

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