The following data is part of a premarket notification filed by Cao Group, Inc. with the FDA for Pilot Diode Laser, Model 002-00139.
| Device ID | K100143 |
| 510k Number | K100143 |
| Device Name: | PILOT DIODE LASER, MODEL 002-00139 |
| Classification | Powered Laser Surgical Instrument |
| Applicant | CAO GROUP, INC. 4628 WEST SKYHAWK DRIVE West Jordan, UT 84084 |
| Contact | Robert Larsen |
| Correspondent | Robert 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 | 2010-01-19 |
| Decision Date | 2010-08-13 |
| Summary: | summary |