The following data is part of a premarket notification filed by Cj Laser Corp. with the FDA for Model Mm-2405 And Mm-2410 Copper Vapor Laser.
| Device ID | K921298 |
| 510k Number | K921298 |
| Device Name: | MODEL MM-2405 AND MM-2410 COPPER VAPOR LASER |
| Classification | Powered Laser Surgical Instrument |
| Applicant | CJ LASER CORP. 3035 DRYDEN RD. Dayton, OH 45439 |
| Contact | Cem Gokay |
| Correspondent | Cem Gokay CJ LASER CORP. 3035 DRYDEN RD. Dayton, OH 45439 |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-03-17 |
| Decision Date | 1992-07-02 |