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 |