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).
| Device ID | K180576 |
| 510k Number | K180576 |
| Device Name: | Solar Storm, Solar Wave, Sunco, And ESB (Avalon, Galaxy, Grande, Oasis, Elite And Leisure Select) |
| Classification | Booth, Sun Tan |
| Applicant | LPI, Inc. 506 Twin Oaks Drive Johnson City, TN 37601 |
| Contact | Christopher Steadman |
| Correspondent | Christopher Steadman LPI, Inc. 506 Twin Oaks Drive Johnson City, TN 37601 |
| Product Code | LEJ |
| CFR Regulation Number | 878.4635 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-03-05 |
| Decision Date | 2018-04-19 |
| Summary: | summary |