The following data is part of a premarket notification filed by Laser Health Technologies, Llc with the FDA for Lasertouchone (otc).
| Device ID | K100116 |
| 510k Number | K100116 |
| Device Name: | LASERTOUCHONE (OTC) |
| Classification | Stimulator, Nerve, Transcutaneous, Over-the-counter |
| Applicant | LASER HEALTH TECHNOLOGIES, LLC 5600 WISCONSIN AVENUE #509 Chevy Chase, MD 20815 |
| Contact | Patsy J Trisler |
| Correspondent | Patsy J Trisler LASER HEALTH TECHNOLOGIES, LLC 5600 WISCONSIN AVENUE #509 Chevy Chase, MD 20815 |
| Product Code | NUH |
| CFR Regulation Number | 882.5890 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-01-15 |
| Decision Date | 2010-04-15 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00869340000305 | K100116 | 000 |