The following data is part of a premarket notification filed by Mnlase, Inc. with the FDA for Model 220-sc Curved Endophotocoagulator Laser.
| Device ID | K944627 |
| 510k Number | K944627 |
| Device Name: | MODEL 220-SC CURVED ENDOPHOTOCOAGULATOR LASER |
| Classification | Powered Laser Surgical Instrument |
| Applicant | MNLASE, INC. 11250 ROGER BACON DR. #10 Reston, VA 22090 |
| Contact | Bruce Heymann |
| Correspondent | Bruce Heymann MNLASE, INC. 11250 ROGER BACON DR. #10 Reston, VA 22090 |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-09-20 |
| Decision Date | 1994-11-03 |