The following data is part of a premarket notification filed by Coopervision, Inc. with the FDA for Mini-halo Co2 Laser System.
| Device ID | K843915 |
| 510k Number | K843915 |
| Device Name: | MINI-HALO CO2 LASER SYSTEM |
| Classification | Powered Laser Surgical Instrument |
| Applicant | COOPERVISION, INC. P.O. BOX 19587 Irvine , CA 92713 - |
| Contact | Douglas G Allen |
| Correspondent | Douglas G Allen COOPERVISION, INC. P.O. BOX 19587 Irvine , CA 92713 - |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-10-04 |
| Decision Date | 1985-05-10 |