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Joule diVa System
FDA 510(k)Class II (US FDA 510(k))
510(k) K213761
by Sciton, Inc
Identifiers
- 510(k) Number
- K213761 FDA 510(k)
- FDA Product Code
- GEX FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 878.4810 FDA 510(k)
- Regulation Number
- 878.4810 FDA 510(k)
- Advisory Committee
- General, Plastic Surgery FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
Palo Alto-based medical device manufacturer Sciton, Inc. has announced that its Joule diVa System has been deemed Substantially Equivalent to an FDA-cleared medical device. As such, the company is now authorized to market and sell its products in all 50 states, including California.
Authorization Coverage (1 country)
Regulatory Authorizations
United States Active
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K213761 | Class II | Active |
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Manufacturer
- Manufacturer
- Sciton, Inc
Sources (1)
- FDA 510(k) K213761 24 fields · synced Jul 18, 2026