The following data is part of a premarket notification filed by Cao Group, Inc. with the FDA for Precise Shp Diode Laser.
| Device ID | K123443 |
| 510k Number | K123443 |
| Device Name: | PRECISE SHP 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 | 2012-11-08 |
| Decision Date | 2013-08-13 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00872320003524 | K123443 | 000 |
| 00872320004606 | K123443 | 000 |
| 00872320004613 | K123443 | 000 |
| 00872320004620 | K123443 | 000 |
| 00872320001742 | K123443 | 000 |
| 00872320001803 | K123443 | 000 |
| 00872320001810 | K123443 | 000 |
| 00872320001940 | K123443 | 000 |
| 00872320001964 | K123443 | 000 |
| 00872320003227 | K123443 | 000 |
| 00872320003234 | K123443 | 000 |
| 00872320003241 | K123443 | 000 |
| 00872320003326 | K123443 | 000 |
| 00872320003333 | K123443 | 000 |
| 00872320003340 | K123443 | 000 |
| 00872320003357 | K123443 | 000 |
| 00872320003463 | K123443 | 000 |
| 00872320003470 | K123443 | 000 |
| 00872320004514 | K123443 | 000 |