The following data is part of a premarket notification filed by Photomedex, Inc. with the FDA for Laserpro Co2 Carbon Dioxide Laser System.
| Device ID | K040234 |
| 510k Number | K040234 |
| Device Name: | LASERPRO CO2 CARBON DIOXIDE LASER SYSTEM |
| Classification | Powered Laser Surgical Instrument |
| Applicant | PHOTOMEDEX, INC. 147 Keystone Drive Montgomeryville, PA 18936 |
| Contact | Bob Rose |
| Correspondent | Bob Rose PHOTOMEDEX, INC. 147 Keystone Drive Montgomeryville, PA 18936 |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-02-02 |
| Decision Date | 2004-04-02 |
| Summary: | summary |