The following data is part of a premarket notification filed by Photomedex, Inc. with the FDA for Laserpro 810, 940 And 980 Diode Laser Systems.
| Device ID | K082721 |
| 510k Number | K082721 |
| Device Name: | LASERPRO 810, 940 AND 980 DIODE LASER SYSTEMS |
| Classification | Powered Laser Surgical Instrument |
| Applicant | PHOTOMEDEX, INC. 147 KEYSTONE DR. Montgomeryville, PA 18936 |
| Contact | Alfred Intintoli |
| Correspondent | Alfred Intintoli PHOTOMEDEX, INC. 147 KEYSTONE DR. 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 | 2008-09-17 |
| Decision Date | 2008-10-28 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 06971858363927 | K082721 | 000 |