The following data is part of a premarket notification filed by Cao Group, Inc. with the FDA for Denlaser, Model 800.
| Device ID | K003541 |
| 510k Number | K003541 |
| Device Name: | DENLASER, MODEL 800 |
| Classification | Powered Laser Surgical Instrument |
| Applicant | CAO GROUP, INC. 627 WEST SANDY PKWY. Sandy, UT 84070 |
| Contact | Tracy S Best |
| Correspondent | Tracy S Best CAO GROUP, INC. 627 WEST SANDY PKWY. Sandy, UT 84070 |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-11-16 |
| Decision Date | 2001-01-25 |