The following data is part of a premarket notification filed by Laser Engineering, Inc. with the FDA for Dual Switch.
| Device ID | K211605 |
| 510k Number | K211605 |
| Device Name: | Dual Switch |
| Classification | Powered Laser Surgical Instrument |
| Applicant | Laser Engineering, Inc. 475 Metroplex Drive Suite 401 Nashville, TN 37211 |
| Contact | Laurie Dobbs |
| Correspondent | Laurie Dobbs Laser Engineering, Inc. 475 Metroplex Drive 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 | 2021-05-25 |
| Decision Date | 2022-09-22 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00855045007510 | K211605 | 000 |