The following data is part of a premarket notification filed by Sportarredo Group S.c. with the FDA for Hpo Exotic, Lp1, Lp2, Lp3, Mastersun 360, Mastersun 360 New Reflector, Vega Lux.
| Device ID | K161394 |
| 510k Number | K161394 |
| Device Name: | HPO Exotic, LP1, 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 | Lara Luzak REGISTRAR CORP. 144 RESEARCH DR 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 | 2016-05-19 |
| Decision Date | 2017-07-06 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08030389004704 | K161394 | 000 |
| 08030389004681 | K161394 | 000 |
| 08030389004667 | K161394 | 000 |
| 08030389004650 | K161394 | 000 |
| 08030389004643 | K161394 | 000 |
| 08030389004636 | K161394 | 000 |