Ellipse Ydun— 510(k) K180406
Substantially EquivalentEllipse A/S
FDA 510(k) clearance K180406 for Ellipse Ydun, Substantially Equivalent on 2018-03-15. Applicant: Ellipse A/S. Device class: 2.
Clearance details
- Applicant
- Ellipse A/S
- Product code
- 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
- Special
- Location
- Hoersholm, DK
Recent devices under product code GEX
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- K262070 — Diode Laser Therapy Systems (DL612A)
- K261841 — Q Switched Nd:YAG Laser machine (QLQW-01)
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More clearances from Ellipse A/S
view all- K192951 — Ellipse Frax 1940 for Ellipse Nordlys and Ellipse Ydun
- K161162 — Frax 1550 for Ellipse Nordlys/ Ellipse Nordlys+, Ellipse Sirius, Ellipse Infinity, Ellipse Mjolner, Ellipse Nordlys Ultra
- K150907 — Ellipse Nordlys/Ellipse Nordlys+, Ellipse Sirius, Ellipse Infinity, Ellipse Mjolner, Ellipse Nordlys Ultra
- K140670 — ELLIPSE I2PL+/ELLIPSE MULTIFLEX+
- K081408 — ELLIPSE MULTIFLEX
Adverse 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.