The following data is part of a premarket notification filed by Directed Energy, Inc. with the FDA for Halo Co Laser System.
| Device ID | K841234 |
| 510k Number | K841234 |
| Device Name: | HALO CO LASER SYSTEM |
| Classification | Powered Laser Surgical Instrument |
| Applicant | DIRECTED ENERGY, INC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-03-22 |
| Decision Date | 1984-07-09 |