Skip to content

Solea

by Convergent Dental, Inc. 4 variants

510(k) K130420

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) K130420 on 12 Jul 2013, active as of 22 Oct 2026. One FDA recall is linked to it.

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

1 closed

Documents

Trust

Unverified

Source FDA 510(k), synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK130420 Date12 Jul 2013ClearedStatusActive

Official records

Recalls

1 recall · FDA

    • Terminated Z-0050-2014 FDA Class II initiated 12 Sep 2013

    Specific error condition could lead to unintended laser emission during laser activation.

Timeline

2 dated events

  1. Cleared FDA 510(k) K130420
  2. Recall initiated FDA recalls Z-0050-2014

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

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

Related clearances

cited in the FDA summary

Clearances this device's FDA summary refers to, and clearances whose summaries refer to it: a citation, not a claim of equivalence.

Cites

Cited by

Source: 510k-lineage (choiben314), CC BY 4.0

Similar devices

Other devices filed under FDA product code GEX (Powered Laser Surgical Instrument).

Other devices from Convergent Dental

  • Solea Model 3.0

    Class II

  • Solea Model 2.0

    Class II

  • Solea Open recall

    Class II

  • Solea

    Class II

See all devices from Convergent Dental →