Dominion Aesthetic Technologies Inc.September 16, 2022

FDA 483 - Dominion Aesthetic Technologies Inc. - September 16, 2022

View on Dashboard

Discuss this record with AI

ChatGPT

Claude

Perplexity

Grok

Copilot

Document or profile

One record shows the event. A profile shows the pattern.

Buy this document for the source file and details behind this single event.

Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.

Explore Dominion Aesthetic Technologies Inc.

Record Details

Dominion Aesthetic Technologies Inc. in Winter Park, FL, a medical device specification developer, was cited for significant deficiencies in its quality system during an FDA inspection. The firm failed to adequately establish and implement procedures for complaint handling, corrective and preventive actions, design control, quality audits, management review, and employee training. Additionally, the company did not submit required electronic product and radiation safety reports for its Eon™ fat reduction medical laser.

Company: Dominion Aesthetic Technologies Inc.
Inspection Date: September 16, 2022
Product Type: Device
Office: Office of Medical Device and Radiological Health Division II
Person: Stanley B. Eugene (investigator)

Open in Dashboard

ID · ca119e3e-3933-4882-a51a-9fc01ff87b11