mJoule
by Sciton, Inc.
mJoule is a multi-modality skin surface treatment system (FDA Class II) made by Sciton, Inc., cleared under FDA 510(k) K182173 on 6 Mar 2019 and listed in FDA GUDID since 9 Jul 2020 (UDI-DI 00863249000329), active as of 21 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number00863249000329 | Date9 Jul 2020 | StatusListed |
| United States | FDA 510(k)SESE | NumberK182173 | Date6 Mar 2019 | StatusActive |
Official records
- AccessGUDID record 00863249000329
- FDA 510(k) database K182173
Across registries
- FDA 510(k) K182173 decided 6 Mar 2019 Active
- FDA GUDID UDI-DI 00863249000329 listed 9 Jul 2020 Listed
Timeline
- Cleared FDA 510(k) K182173
- Listed FDA GUDID 00863249000329
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Generic name
- Multi-modality skin surface treatment system
- Model / reference
- mJoule
- Primary DI / UDI-DI
- 00863249000329
- 510(k) Number
- FDA product code
- ONG, GEX, ONF
- GMDN term
- Multi-modality skin surface treatment system
- Device class
- Class II
- Regulation number
- 878.4810
- GUDID distribution status
- In Commercial Distribution
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