The following data is part of a premarket notification filed by Surgical Laser Technologies, Inc. with the FDA for Modification To: Laserpro 810, 940, And 980 Diode Diode Laser Systems.
| Device ID | K042211 |
| 510k Number | K042211 |
| Device Name: | MODIFICATION TO: LASERPRO 810, 940, AND 980 DIODE DIODE LASER SYSTEMS |
| Classification | Powered Laser Surgical Instrument |
| Applicant | SURGICAL LASER TECHNOLOGIES, INC. 147 KEYSTONE DR. Montgomeryville, PA 18936 |
| Contact | Bob Rose |
| Correspondent | Bob Rose SURGICAL LASER TECHNOLOGIES, INC. 147 KEYSTONE DR. Montgomeryville, PA 18936 |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-08-16 |
| Decision Date | 2004-11-08 |
| Summary: | summary |