The following data is part of a premarket notification filed by Sciton, Inc with the FDA for Mjoule System And Accessories.
| Device ID | K213350 |
| 510k Number | K213350 |
| Device Name: | MJOULE System And Accessories |
| Classification | Powered Laser Surgical Instrument |
| Applicant | Sciton, Inc 925 Commercial Street Palo Alto, CA 94303 |
| Contact | Jay Patel |
| Correspondent | Jay 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 | 2021-10-08 |
| Decision Date | 2022-04-15 |