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

Booth, Sun Tan

LPI, Inc.

The following data is part of a premarket notification filed by Lpi, Inc. with the FDA for Solar Storm, Solar Wave, Sunco, And Esb (avalon, Galaxy, Grande, Oasis, Elite And Leisure Select).

Pre-market Notification Details

Device IDK180576
510k NumberK180576
Device Name:Solar Storm, Solar Wave, Sunco, And ESB (Avalon, Galaxy, Grande, Oasis, Elite And Leisure Select)
ClassificationBooth, Sun Tan
Applicant LPI, Inc. 506 Twin Oaks Drive Johnson City,  TN  37601
ContactChristopher Steadman
CorrespondentChristopher Steadman
LPI, Inc. 506 Twin Oaks Drive Johnson City,  TN  37601
Product CodeLEJ  
CFR Regulation Number878.4635 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2018-03-05
Decision Date2018-04-19
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
G710SW24220V0 K180576 000
G710GAL240 K180576 000
G710GAL220 K180576 000
G710GAL180 K180576 000
G710GAL160 K180576 000
G710AV32 K180576 000
G710AV280 K180576 000
G710AV240 K180576 000
G710AV200 K180576 000
G710AV160 K180576 000
G710GAL300 K180576 000
G710OA360 K180576 000
G710SW24110V0 K180576 000
G710SS24S0 K180576 000
G710SS24R0 K180576 000
G710SS24C0 K180576 000
G710SS48ST0 K180576 000
G710SS36ST0 K180576 000
G710SS32S0 K180576 000
G710SS32R0 K180576 000
G710SS300 K180576 000
G71032C0 K180576 000

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