The following data is part of a premarket notification filed by Directed Energy, Inc. with the FDA for Model 8-b Co2 Laser For Opthalmic & Orbital Surg.
| Device ID | K862408 |
| 510k Number | K862408 |
| Device Name: | MODEL 8-B CO2 LASER FOR OPTHALMIC & ORBITAL SURG |
| 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 | 1986-06-25 |
| Decision Date | 1986-10-24 |