Microperimeter MP-3

FDA 510(k) K152729 · Nidek Co., Ltd.

Substantially Equivalent

510(k) numberK152729

Submission

Device name
Microperimeter MP-3
Applicant
Nidek Co., Ltd.
Gamagori, JP
Received
September 22, 2015
Decision date
June 6, 2016
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
HKI – Camera, Ophthalmic, Ac-Powered
Device class
Class II (moderate risk)
Regulation
21 CFR 886.1120
Specialty
Ophthalmic

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Questions and answers

When was Microperimeter MP-3 cleared by the FDA?

Microperimeter MP-3 (K152729) received a 510(k) decision of Substantially Equivalent on June 6, 2016, 258 days after the submission was received.

What is the product code of K152729?

The FDA product code is HKI – Camera, Ophthalmic, Ac-Powered, a Class II (moderate risk) device regulated under 21 CFR 886.1120.