510(k) Report

FDA applicant

Danish Dermatologic Development A/S

Hoersholm, DK3 decisions2005–20060 recalls

FDA records 3 decisions for Danish Dermatologic Development A/S (Hoersholm, DK) from 2005 to 2006: 3 510(k) clearances. All are in product code GEX (Powered Laser Surgical Instrument). Its devices cite 11 predicates, 3 of them its own earlier devices. No recall is linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, general and plastic surgery panel, where it files most

How often FDA has decided Danish Dermatologic Development A/S’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Danish Dermatologic Development A/S since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Danish Dermatologic Development A/S by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Danish Dermatologic Development A/S’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Which product codes does it file in?

  • GEXPowered Laser Surgical Instrument3decisions

Whose devices does it build on?

Its devices cite 11 predicates; 3 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 11 times; 3 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K060516Ellipse 12PL, Model 9ESL7228Danish Dermatologic Development A/S · 20065cite it
  • K052688Ellipse Flex PPT, Model 9ESF7255Danish Dermatologic Development A/S · 20053cite it
  • K043255Ellipse Light SPTDanish Dermatologic Development A/S · 20053cite it

What has FDA decided for it lately?

  • K060516Ellipse 12PL, Model 9ESL7228Danish Dermatologic Development A/S · 2006
  • K052688Ellipse Flex PPT, Model 9ESF7255Danish Dermatologic Development A/S · 2005
  • K043255Ellipse Light SPTDanish Dermatologic Development A/S · 2005

All 3 as Danish Dermatologic Development A/S →

Other applicant names beginning “Danish”

FDA records each applicant name separately; these may or may not be the same firm.

Danish Diagnostic Development A/S 6