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FDA 510(k)

HPO Exotic, LP1, LP2, LP3, Mastersun 360, Mastersun 360 New Reflector, Vega Lux

K-Number: K161394 · 2017-07-06

ApplicantSportarredo Group S.C.
Decision Date2017-07-06
Product CodeLEJ
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

HPO Exotic, LP1, LP2, LP3, Mastersun 360, Mastersun 360 New Reflector, Vega Lux is the device name listed in this FDA 510(k) record. The listed applicant is Sportarredo Group S.C.. It received FDA 510(k) clearance on 2017-07-06 under 510(k) number K161394. The device is classified under product code LEJ. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HPO Exotic, LP1, LP2, LP3, Mastersun 360, Mastersun 360 New Reflector, Vega Lux?

HPO Exotic, LP1, LP2, LP3, Mastersun 360, Mastersun 360 New Reflector, Vega Lux is a medical device that received FDA 510(k) clearance on 2017-07-06. The listed applicant is Sportarredo Group S.C.. The 510(k) number is K161394.

When did HPO Exotic, LP1, LP2, LP3, Mastersun 360, Mastersun 360 New Reflector, Vega Lux receive FDA 510(k) clearance?

HPO Exotic, LP1, LP2, LP3, Mastersun 360, Mastersun 360 New Reflector, Vega Lux received FDA 510(k) clearance on 2017-07-06, under 510(k) number K161394.

Who is the listed applicant for HPO Exotic, LP1, LP2, LP3, Mastersun 360, Mastersun 360 New Reflector, Vega Lux?

The FDA 510(k) record lists Sportarredo Group S.C. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for HPO Exotic, LP1, LP2, LP3, Mastersun 360, Mastersun 360 New Reflector, Vega Lux?

The FDA product code for HPO Exotic, LP1, LP2, LP3, Mastersun 360, Mastersun 360 New Reflector, Vega Lux is LEJ.

Other records listing Sportarredo Group S.C. 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.

K152233BPhase, HPO Exotic, LPI, LP2, LP3, Mastersun 360, Mastersun 360 New Reflector, Vega Lux

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Official Source

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