Joule System
510(k) K180508
Joule System is a medical device (FDA Class II; FDA product code GEX, Powered Laser Surgical Instrument) made by Sciton, Inc, cleared under FDA 510(k) K180508 on 18 May 2018, active as of 22 Oct 2026.
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 | NumberK180508 | Date18 May 2018 | StatusActive |
Official records
- FDA 510(k) database K180508
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- Withdrawn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
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