The following data is part of a premarket notification filed by Cao Group, Inc. with the FDA for Pilot Ultra Diode Laser.
Device ID | K142226 |
510k Number | K142226 |
Device Name: | Pilot Ultra 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 | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2014-08-13 |
Decision Date | 2014-09-12 |
Summary: | summary |