The following data is part of a premarket notification filed by Sciton, Inc with the FDA for Joule System.
| Device ID | K173285 |
| 510k Number | K173285 |
| Device Name: | JOULE SYSTEM |
| Classification | Powered Laser Surgical Instrument |
| Applicant | Sciton, Inc 925 Commercial Street Palo Alto, CA 94303 |
| Contact | Jay M. Patel |
| Correspondent | Jay M. Patel Sciton, Inc 925 Commercial Street Palo Alto, CA 94303 |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-10-16 |
| Decision Date | 2018-01-29 |
| Summary: | summary |