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FDA 510(k)

Photoelectric Therapy System

K-Number: K172080 · 2017-09-29

ApplicantXstrahl, Ltd.
Decision Date2017-09-29
Product CodeJAD
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Photoelectric Therapy System is the device name listed in this FDA 510(k) record. The listed applicant is Xstrahl, Ltd.. It received FDA 510(k) clearance on 2017-09-29 under 510(k) number K172080. 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 Photoelectric Therapy System?

Photoelectric Therapy System is a medical device that received FDA 510(k) clearance on 2017-09-29. The listed applicant is Xstrahl, Ltd.. The 510(k) number is K172080.

When did Photoelectric Therapy System receive FDA 510(k) clearance?

Photoelectric Therapy System received FDA 510(k) clearance on 2017-09-29, under 510(k) number K172080.

Who is the listed applicant for Photoelectric Therapy System?

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 Photoelectric Therapy System?

The FDA product code for Photoelectric Therapy System 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)K230611X80 / RADiant / PhotoElectric Therapy System (RADiant Aura)

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, AGK230611X80 / RADiant / PhotoElectric Therapy System (RADiant Aura)Xstrahl, Ltd.K213942EsteyaNucletron B.V.K190255Sensus Healthcare TVM Balloon ApplicatorSensus Healthcare, Inc.K182641Sensus IORT SystemSensus 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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