The following data is part of a premarket notification filed by Blueshine Srl with the FDA for Blueshine Light Shine Systems, Sp, Twin And Compact Sp.
| Device ID | K063060 |
| 510k Number | K063060 |
| Device Name: | BLUESHINE LIGHT SHINE SYSTEMS, SP, TWIN AND COMPACT SP |
| Classification | Powered Laser Surgical Instrument |
| Applicant | BLUESHINE SRL VIA OLIVI 2 Mestre, Venice, IT 30171 |
| Contact | Alice Novelli |
| Correspondent | Mark Job REGULATORY TECHNOLOGY SERVICES, LLC 1000 Westgate Drive, Suite 510k Saint Paul, MN 55114 |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2006-10-05 |
| Decision Date | 2006-11-29 |
| Summary: | summary |