LunulaLaser
Lasers For Temporary Increase Of Clear Nail In Patients With Onychomycosis
ERCHONIA MEDICAL, INC.
The following data is part of a premarket notification filed by Erchonia Medical, Inc. with the FDA for Lunulalaser.
Pre-market Notification Details
| Device ID | K153164 |
| 510k Number | K153164 |
| Device Name: | LunulaLaser |
| Classification | Lasers For Temporary Increase Of Clear Nail In Patients With Onychomycosis |
| Applicant | ERCHONIA MEDICAL, INC. 2021 COMMERCE DR. Mckinney, TX 75069 |
| Contact | Steve Shanks |
| Correspondent | Kevin Walls REGULATORY INSIGHT, INC. 33 GOLDEN EAGLE LANE Littleton, CO 80127 |
| Product Code | PDZ |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-11-02 |
| Decision Date | 2016-06-03 |
Trademark Results [LunulaLaser]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 LUNULALASER 85514416 4227819 Live/Registered |
Erchonia Corporation 2012-01-11 |
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