The following data is part of a premarket notification filed by Cao Group, Inc. with the FDA for Denlaser 800 Plus.
| Device ID | K062619 |
| 510k Number | K062619 |
| Device Name: | DENLASER 800 PLUS |
| Classification | Powered Laser Surgical Instrument |
| Applicant | CAO GROUP, INC. 4628 WEST SKYHAWK DRIVE West Jordan, UT 84084 |
| Contact | Robert K Larsen |
| Correspondent | Robert K Larsen CAO GROUP, INC. 4628 WEST SKYHAWK DRIVE West Jordan, UT 84084 |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-09-05 |
| Decision Date | 2006-11-14 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00872320003494 | K062619 | 000 |
| 00872320001391 | K062619 | 000 |
| 00872320001438 | K062619 | 000 |
| 00872320001872 | K062619 | 000 |
| 00872320002534 | K062619 | 000 |
| 00872320002541 | K062619 | 000 |
| 00872320002633 | K062619 | 000 |
| 00872320003173 | K062619 | 000 |
| 00872320003265 | K062619 | 000 |
| 00872320003388 | K062619 | 000 |
| 00872320003395 | K062619 | 000 |
| 00872320003432 | K062619 | 000 |
| 00872320003449 | K062619 | 000 |
| 00872320003487 | K062619 | 000 |
| 00872320001360 | K062619 | 000 |