510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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Ellipse A/S

Hoersholm, DK

Ellipse A/S appears in FDA device records in Hoersholm, DK. FDA records list 7 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show 2 recalls for this company.

FDA records held for this company

510(k) clearances
7
PMA records
0
Recall records
2
Registered establishments
0

510(k) clearance history

FDA records hold 7 510(k) clearances for Ellipse A/S between 2007 and 2020. The busiest year on record is 2007, with 1. The most recent is 2020, with 1.

Clearances by year, as a table
510(k) clearance decisions for Ellipse A/S, by decision year
YearClearances
20071
20081
20141
20151
20161
20181
20201
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K192951Ellipse Frax 1940 for Ellipse Nordlys and Ellipse YdunGEXSubstantially Equivalent
K180406Ellipse YdunGEXSubstantially Equivalent
K161162Frax 1550 for Ellipse Nordlys/ Ellipse Nordlys+, Ellipse Sirius, Ellipse Infinity, Ellipse Mjolner, Ellipse Nordlys UltraGEXSubstantially Equivalent
K150907Ellipse Nordlys/Ellipse Nordlys+, Ellipse Sirius, Ellipse Infinity, Ellipse Mjolner, Ellipse Nordlys UltraGEXSubstantially Equivalent
K140670ELLIPSE I2PL+/ELLIPSE MULTIFLEX+ONFSubstantially Equivalent
K081408ELLIPSE MULTIFLEXGEXSubstantially Equivalent
K072023ELLIPSE JUVIA, MODEL 9EJU7465GEXSubstantially Equivalent

Registered establishments

No FDA establishment registrations recorded against this company.

FDA product codes

Recall records

Device recall records naming this company, most recent first
RecallProductReasonClassificationInitiatedStatus
Z-1698-2016Ellipse ND: YAG Laser applicator for Ellipse Nordlys system Medical Laser Products.Failure to provide the required instructions specifying a procedure and schedule for calibration of the measurement system.Class IITerminated
Z-1697-2016Ellipse ND: YAG Laser applicator for Ellipse Multiflex Medical Laser Products.Failure to provide the required instructions specifying a procedure and schedule for calibration of the measurement system.Class IITerminated

Verification record

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Data as of , FDA export datePage updated Source: openFDA, public domain