510(k) K113843
K113843 is an FDA 510(k) premarket notification submitted by Lutronic Corporation for the device "FREEDOM ND: YAG LASER SYSTEM". The FDA issued a decision of Substantially Equivalent on September 27, 2012. The device falls under product code PDZ (Lasers For Temporary Increase Of Clear Nail In Patients With Onychomycosis), a Class II device regulated under 21 CFR 878.4810. Lutronic Corporation has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 27, 2012
- Date Received
- December 28, 2011
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Lasers For Temporary Increase Of Clear Nail In Patients With Onychomycosis
- Device Class
- Class II
- Regulation Number
- 878.4810
- Review Panel
- SU
- Submission Type
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.).