The following data is part of a premarket notification filed by Sandstone Medical Technologies, Llc with the FDA for Ls Family Of Co2 Lasers Including: Ls-15 Laser System (15 Watt) And Ls-25 Laser System (25 Watt).
| Device ID | K040563 |
| 510k Number | K040563 |
| Device Name: | LS FAMILY OF CO2 LASERS INCLUDING: LS-15 LASER SYSTEM (15 WATT) AND LS-25 LASER SYSTEM (25 WATT) |
| 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 | 2004-03-03 |
| Decision Date | 2004-10-08 |
| Summary: | summary |