The following data is part of a premarket notification filed by Laser Spectrum, Inc. with the FDA for Model 305aa Portable Laser.
| Device ID | K841781 |
| 510k Number | K841781 |
| Device Name: | MODEL 305AA PORTABLE LASER |
| Classification | Powered Laser Surgical Instrument |
| Applicant | LASER SPECTRUM, INC. 100 SOUTH WACKER DRIVE Chicago , IL 60606 - |
| Contact | Robert W Browne |
| Correspondent | Robert W Browne LASER SPECTRUM, INC. 100 SOUTH WACKER DRIVE Chicago , IL 60606 - |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-04-30 |
| Decision Date | 1984-11-07 |