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 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 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 |