EVA,anterior machine, EVA, combined machine, EVA combined machine with laser(DORC connector), EVA combined machine with laser SMA connector)

FDA 510(k) K142877 · Dutch Ophthalmic Research Center International BV

Substantially Equivalent

510(k) numberK142877

Submission

Device name
EVA,anterior machine, EVA, combined machine, EVA combined machine with laser(DORC connector), EVA combined machine with laser SMA connector)
Applicant
Dutch Ophthalmic Research Center International BV
Zuidland, NL
Received
October 1, 2014
Decision date
March 13, 2015
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
HQC – Unit, Phacofragmentation
Device class
Class II (moderate risk)
Regulation
21 CFR 886.4670
Specialty
Ophthalmic

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Questions and answers

When was EVA,anterior machine, EVA, combined machine, EVA combined machine with laser(DORC connector), EVA combined machine with laser SMA connector) cleared by the FDA?

EVA,anterior machine, EVA, combined machine, EVA combined machine with laser(DORC connector), EVA combined machine with laser SMA connector) (K142877) received a 510(k) decision of Substantially Equivalent on March 13, 2015, 163 days after the submission was received.

What is the product code of K142877?

The FDA product code is HQC – Unit, Phacofragmentation, a Class II (moderate risk) device regulated under 21 CFR 886.4670.