The following data is part of a premarket notification filed by Photo Medex, Inc. with the FDA for Xtrac Ultra 2, Model Al10000.
| Device ID | K073659 |
| 510k Number | K073659 |
| Device Name: | XTRAC ULTRA 2, MODEL AL10000 |
| Classification | Powered Laser Surgical Instrument |
| Applicant | PHOTO MEDEX, INC. 2375 CAMINO VIDA ROBLE, SUITE B Carlsbad, CA 92011 |
| Contact | Jeff Levatter |
| Correspondent | Jeff Levatter PHOTO MEDEX, INC. 2375 CAMINO VIDA ROBLE, SUITE B Carlsbad, CA 92011 |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-12-26 |
| Decision Date | 2008-03-05 |
| Summary: | summary |