510(k) K123014
K123014 is an FDA 510(k) premarket notification submitted by Litecure, LLC for the device "LITECURE THERAPY SYSTEM MODEL LTS-1500". The FDA issued a decision of Substantially Equivalent on March 29, 2013. 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. Litecure, LLC has at least 6 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 29, 2013
- Date Received
- September 27, 2012
- 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.).