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FDA 510(k)

Solar Storm, Solar Wave, Sunco, and ESB (Avalon, Galaxy, Grande, Oasis, Elite and Leisure Select)

K-Number: K180576 · 2018-04-19

ApplicantLpi, Inc.
Decision Date2018-04-19
Product CodeLEJ
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Solar Storm, Solar Wave, Sunco, and ESB (Avalon, Galaxy, Grande, Oasis, Elite and Leisure Select) is the device name listed in this FDA 510(k) record. The listed applicant is Lpi, Inc.. It received FDA 510(k) clearance on 2018-04-19 under 510(k) number K180576. 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 Solar Storm, Solar Wave, Sunco, and ESB (Avalon, Galaxy, Grande, Oasis, Elite and Leisure Select)?

Solar Storm, Solar Wave, Sunco, and ESB (Avalon, Galaxy, Grande, Oasis, Elite and Leisure Select) is a medical device that received FDA 510(k) clearance on 2018-04-19. The listed applicant is Lpi, Inc.. The 510(k) number is K180576.

When did Solar Storm, Solar Wave, Sunco, and ESB (Avalon, Galaxy, Grande, Oasis, Elite and Leisure Select) receive FDA 510(k) clearance?

Solar Storm, Solar Wave, Sunco, and ESB (Avalon, Galaxy, Grande, Oasis, Elite and Leisure Select) received FDA 510(k) clearance on 2018-04-19, under 510(k) number K180576.

Who is the listed applicant for Solar Storm, Solar Wave, Sunco, and ESB (Avalon, Galaxy, Grande, Oasis, Elite and Leisure Select)?

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

What is the FDA product code for Solar Storm, Solar Wave, Sunco, and ESB (Avalon, Galaxy, Grande, Oasis, Elite and Leisure Select)?

The FDA product code for Solar Storm, Solar Wave, Sunco, and ESB (Avalon, Galaxy, Grande, Oasis, Elite and Leisure Select) is LEJ.

Related Devices (Code: LEJ)

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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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