The following data is part of a premarket notification filed by Sandstone Medical Technologies, Llc with the FDA for Ultralight Ii Nd:yag Laser System.
| Device ID | K041011 |
| 510k Number | K041011 |
| Device Name: | ULTRALIGHT II ND:YAG LASER SYSTEM |
| Classification | Powered Laser Surgical Instrument |
| Applicant | SANDSTONE MEDICAL TECHNOLOGIES, LLC 908 STETSON STREET Woodland, CA 95776 |
| Contact | Connie White Hoy |
| Correspondent | Connie White Hoy SANDSTONE MEDICAL TECHNOLOGIES, LLC 908 STETSON STREET Woodland, CA 95776 |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-04-20 |
| Decision Date | 2004-12-14 |
| Summary: | summary |