The following data is part of a premarket notification filed by Footdocprenur, Llc with the FDA for Remy Medical Therapy Laser System.
| Device ID | K190034 |
| 510k Number | K190034 |
| Device Name: | REMY Medical Therapy Laser System |
| Classification | Lasers For Temporary Increase Of Clear Nail In Patients With Onychomycosis |
| Applicant | Footdocprenur, LLC 1803 Country Club Drive Cherry Hill, NJ 08003 |
| Contact | David Zuckerman |
| Correspondent | Alexander Braun Henderson BraunSolutions 970 South Dawson Way Unit 14 Aurora, CO 80012 |
| Product Code | PDZ |
| Subsequent Product Code | GEX |
| Subsequent Product Code | ILY |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-01-07 |
| Decision Date | 2019-05-15 |