K111483 is an FDA 510(k) clearance for the JOULE CLEARSENSE LASER SYSTEM. This device is classified as a Lasers For Temporary Increase Of Clear Nail In Patients With Onychomycosis (Class II - Special Controls, product code PDZ).
Submitted by Sciton, Inc (Palo Alto, US). The FDA issued a Cleared decision on December 7, 2011, 190 days after receiving the submission on May 31, 2011.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4810. 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.)..
| 510(k) Number | K111483 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 31, 2011 |
| Decision Date | December 07, 2011 |
| Days to Decision | 190 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | PDZ — Lasers For Temporary Increase Of Clear Nail In Patients With Onychomycosis |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 878.4810 |
| Definition | 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.). |