510(k) K111483
K111483 is an FDA 510(k) premarket notification submitted by Sciton, Inc for the device "JOULE CLEARSENSE LASER SYSTEM". The FDA issued a decision of Substantially Equivalent on December 7, 2011. 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. Sciton, Inc has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 7, 2011
- Date Received
- May 31, 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.).