The following data is part of a premarket notification filed by Laser Health Technologies, Llc with the FDA for Laser Touchone.
| Device ID | K083822 |
| 510k Number | K083822 |
| Device Name: | LASER TOUCHONE |
| Classification | Stimulator, Nerve, Transcutaneous, For Pain Relief |
| Applicant | LASER HEALTH TECHNOLOGIES, LLC 5600 WISCONSIN AVE., SUITE 509 Chevy Chase, MD 20815 |
| Contact | Patsy Trisler |
| Correspondent | Patsy Trisler LASER HEALTH TECHNOLOGIES, LLC 5600 WISCONSIN AVE., SUITE 509 Chevy Chase, MD 20815 |
| Product Code | GZJ |
| CFR Regulation Number | 882.5890 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-12-22 |
| Decision Date | 2009-05-06 |
| Summary: | summary |