510(k) Report

FDA applicant

Ellipse A/S

Hoersholm, DK7 decisions2007–20201 recall

FDA records 7 decisions for Ellipse A/S (Hoersholm, DK) from 2007 to 2020: 7 510(k) clearances. Most are in product codes GEX (Powered Laser Surgical Instrument) and ONF (Powered Light Based Non-Laser Surgical…). Since 2016 its 510(k)s took a median of 144 days from receipt to decision, against 90 for FDA’s reviews in the same codes and years. Its devices cite 19 predicates, 4 of them its own earlier devices. 1 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 Ellipse A/S’s devices, and how often a recall has named them.

FDA decisions per year

1in 2020

2007: 12008: 12014: 12015: 12016: 12018: 12020: 1
2007high 1 (2007) · low 0 (2009)2026

2026 so far, outlined.

Recalls per year

1in 2016

2016: 1
2007high 1 (2016) · low 0 (2007)2026

Class I Class II/III not classified

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

Planning a device like Ellipse 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 Instrument6decisions
  • ONFPowered Light Based Non-Laser Surgical Instrument With Thermal Effect1decision

How long do its 510(k) reviews take?

Since 2016, its 3 510(k)s took a median of 144 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 90 days; 1 of its 3 were faster than that.

Whose devices does it build on?

Its devices cite 19 predicates; 4 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 7 times; 4 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.

  • K150907Ellipse Nordlys/Ellipse Nordlys+, Ellipse Sirius, Ellipse Infinity, Ellipse Mjolner, Ellipse Nordlys UltraEllipse A/S · 20152cite it
  • K161162Frax 1550 for Ellipse Nordlys/ Ellipse Nordlys+, Ellipse Sirius, Ellipse Infinity, Ellipse Mjolner, Ellipse…Ellipse A/S · 20162cite it
  • K140670Ellipse I2PL+/Ellipse Multiflex+Ellipse A/S · 20141cites it
  • K192951Ellipse Frax 1940 for Ellipse Nordlys and Ellipse YdunEllipse A/S · 20201cites it
  • K081408Ellipse MultiflexEllipse A/S · 20081cites it

What has FDA decided for it lately?

  • K192951Ellipse Frax 1940 for Ellipse Nordlys and Ellipse YdunEllipse A/S · 2020
  • K180406Ellipse YdunEllipse A/S · 2018
  • K161162Frax 1550 for Ellipse Nordlys/ Ellipse Nordlys+, Ellipse Sirius, Ellipse Infinity, Ellipse Mjolner, Ellipse…Ellipse A/S · 2016
  • K150907Ellipse Nordlys/Ellipse Nordlys+, Ellipse Sirius, Ellipse Infinity, Ellipse Mjolner, Ellipse Nordlys UltraEllipse A/S · 2015
  • K140670Ellipse I2PL+/Ellipse Multiflex+Ellipse A/S · 20141 recall
  • K081408Ellipse MultiflexEllipse A/S · 2008
  • K072023Ellipse Juvia, Model 9EJU7465Ellipse A/S · 2007

All 7 as Ellipse A/S →

What has been recalled?

1 recall linked to its devices; the latest:

  • K140670Ellipse ND: YAG Laser applicator for Ellipse Multiflex Medical Laser Products.May 5, 2016Class II

Other applicant names beginning “Ellipse”

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

Ellipse Technologies, Inc. 20