The following data is part of a premarket notification filed by Laser Engineering, Inc. with the FDA for Dual Switch.
| Device ID | K141908 |
| 510k Number | K141908 |
| Device Name: | DUAL SWITCH |
| Classification | Powered Laser Surgical Instrument |
| Applicant | LASER ENGINEERING, INC. 475 METROPLEX DR. SUITE 401 Nashville, TN 37211 |
| Contact | Laurie Dobbs |
| Correspondent | Laurie Dobbs LASER ENGINEERING, INC. 475 METROPLEX DR. SUITE 401 Nashville, TN 37211 |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-07-15 |
| Decision Date | 2014-10-22 |
| Summary: | summary |