The following data is part of a premarket notification filed by Sciton, Inc. with the FDA for Joule Clearsense Laser System.
| Device ID | K111483 |
| 510k Number | K111483 |
| Device Name: | JOULE CLEARSENSE LASER SYSTEM |
| Classification | Lasers For Temporary Increase Of Clear Nail In Patients With Onychomycosis |
| Applicant | SCITON, INC. 925 COMMERCIAL ST. Palo Alto, CA 94303 |
| Contact | Jay M Patel |
| Correspondent | Jay M Patel SCITON, INC. 925 COMMERCIAL ST. Palo Alto, CA 94303 |
| Product Code | PDZ |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-05-31 |
| Decision Date | 2011-12-07 |
| Summary: | summary |