The following data is part of a premarket notification filed by Lutronic Corporation with the FDA for Freedom Nd: Yag Laser System.
| Device ID | K113843 |
| 510k Number | K113843 |
| Device Name: | FREEDOM ND: YAG LASER SYSTEM |
| Classification | Lasers For Temporary Increase Of Clear Nail In Patients With Onychomycosis |
| Applicant | LUTRONIC CORPORATION 6 NESHAMINY INTERPLEX, SUITE 207 Trevose, PA 19053 |
| Contact | Jhung Won Vojir |
| Correspondent | Jhung Won Vojir LUTRONIC CORPORATION 6 NESHAMINY INTERPLEX, SUITE 207 Trevose, PA 19053 |
| Product Code | PDZ |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-12-28 |
| Decision Date | 2012-09-27 |
| Summary: | summary |