The following data is part of a premarket notification filed by Cao Group, Inc. with the FDA for Pioneer Elite Diode Laser.
| Device ID | K181602 |
| 510k Number | K181602 |
| Device Name: | Pioneer Elite Diode Laser |
| 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 | 2018-06-19 |
| Decision Date | 2019-09-10 |
| Summary: | summary |