RegWardenFDA facility compliance records
Facility

Solta Medical, Inc.

4 recall(s) on record — most severe on record: Class II.

Activity by year

FDA actions on record by year2014: 1 recalls; 2016: 1 inspections; 2017: 1 recalls; 2019: 1 recalls; 2023: 1 recalls1’14’151’161’17’181’19’20’21’221’23’24’25’26
  • Recalls (4)
  • Inspections (1)

Devices registered here (1)

  • Powered Laser Surgical Instrument With MicrobeamFractional Output
    Product code ONG (opens in a new tab) · Class II · General, Plastic Surgery · 21 CFR 878.4810

Recalls & enforcement

  • Class IIOngoing2023-02-16
    A service unit was potentially improperly tested and calibrated during manufacturing on a failed test station.
  • Class IITerminated2019-12-30
    Complaints of sparking of the tips of the electrosurgical device used in RF surgical procedures. The use of the affected treatment tips could contribute to potential skin burns.
  • Class IITerminated2017-06-01
    Potential inaccurate calibration by service depot repair, which could contribute to patients being burnt by the device. This only impacts units serviced between the dates of 09/08/2016 and 05/23/2017.
  • Class IITerminated2014-03-20
    Obsolete versions of the Laser Treatment Settings card for the Fraxel DUAL 1550/1927 Laser system may have contained incorrect indication for use for treatment of Melasma.

FDA inspections (1)

  • VAI2016-01-15
    Voluntary Action Indicated · Compliance: Devices; Postmarket Assurance: Devices · citations posted

Source: U.S. FDA Inspections Dashboard (opens in a new tab) (device inspection classifications, 2016–present). Data as of 2026-10-06. The dashboard profile can take several seconds to load.

Related

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this facility record at FDA → (opens in a new tab)

Cite this record

RegWarden. “Solta Medical, Inc. (FEI 3004106598) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3004106598-solta-medical-inc/

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