mJOULE System and Accessories
by Sciton, Inc
510(k) K213350
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK213350 | Date15 Apr 2022 | StatusActive |
Official records
- FDA 510(k) database K213350
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- GEX
- Device class
- Class II
- Regulation
- 21 CFR Part 878.4810
- Advisory committee
- General, Plastic Surgery
- FDA decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 23 Sep 2026
The mJOULE System and Accessories is a device used in general and plastic surgery procedures. It is substantially equivalent to a legally marketed device as determined by FDA 510(k) clearance.
The system is supplied by Sciton, Inc and was cleared via the traditional 510(k) pathway under product code GEX. It received FDA clearance on April 15, 2022, under K213350.
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