The following data is part of a premarket notification filed by Laser, Inc. with the FDA for Model Jm-1 Co2 Laser.
| Device ID | K892912 |
| 510k Number | K892912 |
| Device Name: | MODEL JM-1 CO2 LASER |
| Classification | Powered Laser Surgical Instrument |
| Applicant | LASER, INC. 266 EAST 3200 NORTH Provo, UT 84604 |
| Contact | J Stoddard |
| Correspondent | J Stoddard LASER, INC. 266 EAST 3200 NORTH Provo, UT 84604 |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-04-20 |
| Decision Date | 1990-03-06 |