Solea
by Convergent Dental, Inc. 4 variants
510(k) K123494
Solea is a medical device (FDA Class II; FDA product code GEX, Powered Laser Surgical Instrument) made by Convergent Dental, Inc., cleared under FDA 510(k) K123494 on 11 Feb 2013, active as of 22 Oct 2026. One FDA recall is linked to it.
Active
510(k)
Valid until
No expiry
FDA recalls
None ongoingDocuments
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK123494 | Date11 Feb 2013 | StatusActive |
Official records
- FDA 510(k) database K123494
Recalls
-
- Terminated Z-0050-2014
Specific error condition could lead to unintended laser emission during laser activation.
Timeline
- Cleared FDA 510(k) K123494
- Recall initiated FDA recalls Z-0050-2014
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- Withdrawn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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