The following data is part of a premarket notification filed by Photo Medex, Inc. with the FDA for Xtrac Xl, Model Al8000.
| Device ID | K041943 |
| 510k Number | K041943 |
| Device Name: | XTRAC XL, MODEL AL8000 |
| Classification | Powered Laser Surgical Instrument |
| Applicant | PHOTO MEDEX, INC. 2431 IMPALA DR. Carlsbad, CA 92008 -7227 |
| Contact | Bob Rose |
| Correspondent | Bob Rose PHOTO MEDEX, INC. 2431 IMPALA DR. Carlsbad, CA 92008 -7227 |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-07-19 |
| Decision Date | 2004-10-14 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 010822603 | K041943 | 000 |
| 010822602 | K041943 | 000 |