The following data is part of a premarket notification filed by Directed Energy, Inc. with the FDA for Mini-halo(hand-held) Co2 Laser System.
| Device ID | K853319 |
| 510k Number | K853319 |
| Device Name: | MINI-HALO(HAND-HELD) CO2 LASER SYSTEM |
| Classification | Powered Laser Surgical Instrument |
| Applicant | DIRECTED ENERGY, INC. 11661 SAN VICENTE BLVD. SUITE 203 Los Angeles, CA 90049 |
| Contact | Edward Johansen |
| Correspondent | Edward Johansen DIRECTED ENERGY, INC. 11661 SAN VICENTE BLVD. SUITE 203 Los Angeles, CA 90049 |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-08-07 |
| Decision Date | 1985-09-19 |