The following data is part of a premarket notification filed by Laserscope with the FDA for Gemini Surgical Laser System & Accessories.
| Device ID | K034011 |
| 510k Number | K034011 |
| Device Name: | GEMINI SURGICAL LASER SYSTEM & ACCESSORIES |
| Classification | Powered Laser Surgical Instrument |
| Applicant | LASERSCOPE 3070 ORCHARD DR. San Jose, CA 95134 -2011 |
| Contact | Paul Hardiman |
| Correspondent | Paul Hardiman LASERSCOPE 3070 ORCHARD DR. San Jose, CA 95134 -2011 |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-12-24 |
| Decision Date | 2004-03-30 |
| Summary: | summary |