The following data is part of a premarket notification filed by Prosun International Llc with the FDA for Prosun Sunlamp Products, Luxura Sunlamp Products.
| Device ID | K181455 |
| 510k Number | K181455 |
| Device Name: | ProSun Sunlamp Products, Luxura Sunlamp Products |
| Classification | Booth, Sun Tan |
| Applicant | ProSun International LLC 2442 23rd Street North Saint Petersburg, FL 33713 |
| Contact | Tom Henkemans |
| Correspondent | Jennifer C. Henkemans ProSun International LLC 2442 23rd Street North Saint Petersburg, FL 33713 |
| Product Code | LEJ |
| CFR Regulation Number | 878.4635 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-06-04 |
| Decision Date | 2018-09-10 |
| Summary: | summary |