LunulaLaser
FDA 510(k) K153164 · Erchonia Medical, Inc.
510(k) numberK153164
Submission
- Device name
- LunulaLaser
- Applicant
- Erchonia Medical, Inc.
Mckinney, TX, US - Received
- November 2, 2015
- Decision date
- June 3, 2016
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- PDZ – Lasers For Temporary Increase Of Clear Nail In Patients With Onychomycosis
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 878.4810
- Specialty
- General, Plastic Surgery
For the temporary increase of clear nail in patients with onychomycosis (e.g., dermatophytes Trichophyton rubrum and T mentagrophytes, and/or yeasts Candida albicans, etc.).
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More from Sheaumann Laser, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K132940 | Erchonia AllayNHN · Traditional | 04/14/2014SE |
| K130996 | Erchonia EmergeNHN · Traditional | 09/16/2013SE |
| K130922 | Erchonia Verju Laser System with MassagerOLI · Traditional | 05/17/2013SE |
| K130741 | Erchonia PL5000NHN · Traditional | 04/23/2013SE |
| K120257 | MLS, Zerona-AdOLI · Traditional | 05/14/2012SE |
| K072206 | Erchonia Eml LaserNHN · Traditional | 04/24/2008SE |
| K062792 | Erchonia IOTO_240EGJ · Traditional | 03/01/2007SE |
| K050672 | Erchonia Evrl LaserGEX · Traditional | 05/02/2005SE |
| K041139 | Erchonia Eml LaserNHN · Traditional | 09/30/2004SE |
Questions and answers
When was LunulaLaser cleared by the FDA?
LunulaLaser (K153164) received a 510(k) decision of Substantially Equivalent on June 3, 2016, 214 days after the submission was received.
What is the product code of K153164?
The FDA product code is PDZ – Lasers For Temporary Increase Of Clear Nail In Patients With Onychomycosis, a Class II (moderate risk) device regulated under 21 CFR 878.4810.