The following data is part of a premarket notification filed by W & R Investments, Llc Dba Laser Engineering with the FDA for Ultralase Flexible Co2 Laser Waveguide.
| Device ID | K211761 |
| 510k Number | K211761 |
| Device Name: | UltraLase Flexible CO2 Laser Waveguide |
| Classification | Powered Laser Surgical Instrument |
| Applicant | W & R Investments, LLC Dba Laser Engineering 113 Cedar Street, SuiteS5 Milford, MA 10757 |
| Contact | Robert I Rudko |
| Correspondent | Robert I Rudko W & R Investments, LLC Dba Laser Engineering 113 Cedar Street, SuiteS5 Milford, MA 10757 |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-06-08 |
| Decision Date | 2021-07-30 |