The following data is part of a premarket notification filed by Laser Engineering, Inc. with the FDA for Compulse Co2 Surgical Laser Sys..
| Device ID | K911852 |
| 510k Number | K911852 |
| Device Name: | COMPULSE CO2 SURGICAL LASER SYS. |
| Classification | Powered Laser Surgical Instrument |
| Applicant | LASER ENGINEERING, INC. 113 CEDAR ST. Milford, MA 01757 |
| Contact | Robert I.rudko |
| Correspondent | Robert I.rudko LASER ENGINEERING, INC. 113 CEDAR ST. 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 | 1991-04-26 |
| Decision Date | 1991-06-07 |