The following data is part of a premarket notification filed by Sportarredo Group S.c. with the FDA for Bphase, Hpo Exotic, Lpi, Lp2, Lp3, Mastersun 360, Mastersun 360 New Reflector, Vega Lux.
| Device ID | K152233 |
| 510k Number | K152233 |
| Device Name: | BPhase, HPO Exotic, LPI, LP2, LP3, Mastersun 360, Mastersun 360 New Reflector, Vega Lux |
| Classification | Booth, Sun Tan |
| Applicant | Sportarredo Group S.C. Via Dell' Industria 7 Gruaro, IT 30020 |
| Contact | Stefano Iridio |
| Correspondent | Rhonda Alexander Registrar Corp 144 Research Drive Hampton, VA 23666 |
| Product Code | LEJ |
| CFR Regulation Number | 878.4635 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-08-07 |
| Decision Date | 2016-01-27 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08030389004698 | K152233 | 000 |