The following data is part of a premarket notification filed by W And R Investments Dba Laser Engineering with the FDA for Ultralase Flexible Co2 Laser Waveguide.
| Device ID | K112166 |
| 510k Number | K112166 |
| Device Name: | ULTRALASE FLEXIBLE CO2 LASER WAVEGUIDE |
| Classification | Powered Laser Surgical Instrument |
| Applicant | W AND R INVESTMENTS DBA LASER ENGINEERING 113 CEDAR STREET Milford, MA 01757 |
| Contact | Robert I Rudko |
| Correspondent | Robert I Rudko W AND R INVESTMENTS DBA LASER ENGINEERING 113 CEDAR STREET Milford, MA 01757 |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-07-28 |
| Decision Date | 2011-10-21 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00866988000247 | K112166 | 000 |
| 10866988000237 | K112166 | 000 |
| 00866988000209 | K112166 | 000 |
| 10866988000268 | K112166 | 000 |