The following data is part of a premarket notification filed by Blueshine Srl with the FDA for Blueshine's Gold Series.
| Device ID | K110375 |
| 510k Number | K110375 |
| Device Name: | BLUESHINE'S GOLD SERIES |
| Classification | Lasers For Temporary Increase Of Clear Nail In Patients With Onychomycosis |
| Applicant | BLUESHINE SRL VIA G. QUERINI 27 Mestre, IT 30171 |
| Contact | Chiara Ricci |
| Correspondent | Chiara Ricci BLUESHINE SRL VIA G. QUERINI 27 Mestre, IT 30171 |
| Product Code | PDZ |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-02-09 |
| Decision Date | 2012-02-23 |
| Summary: | summary |