VANISH PRO— 510(k) K253765
Substantially EquivalentDdc Technologies, Inc.
FDA 510(k) clearance K253765 for VANISH PRO, Substantially Equivalent on 2026-04-22. Applicant: Ddc Technologies, Inc.. Device class: 2.
Summary
VANISH PRO comes from Ddc Technologies and is filed under product code GEX (Powered Laser Surgical Instrument). The record doesn't describe the device beyond its name and that code name.
Class II, 21 CFR 878.4810. General and Plastic Surgery is both the classification panel and the review panel, and it came in as a Traditional 510(k).
Ddc Technologies filed from Oceanside, New York. The decision came 148 calendar days after FDA received it (November 25, 2025 to April 22, 2026).
Clearance details
- Applicant
- Ddc Technologies, Inc.
- Product code
- Product code GEX
- Device class
- Class 2
- Regulation
- 21 CFR 878.4810
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Oceanside, NY, US
Recent devices under product code GEX
view allMore clearances from Ddc Technologies, Inc.
view allAdverse events under product code GEX
product code GEX- Death
- 33
- Injury
- 3,045
- Malfunction
- 12,903
- Other
- 25
- Total
- 16,006
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.