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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 a medical device manufactured by Sportarredo Group S.C.. It received FDA 510(k) clearance on 2017-07-06 under approval 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. It is manufactured by Sportarredo Group S.C.. The 510(k) number is K161394.

When was HPO Exotic, LP1, LP2, LP3, Mastersun 360, Mastersun 360 New Reflector, Vega Lux approved by the FDA?

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

What company makes 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 manufactured by Sportarredo Group S.C..

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 Devices by Sportarredo Group S.C.

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

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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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