Z5 Slit lamp microscope, Z2 Slit lamp microscope

FDA 510(k) K152535 · Takagi Seiko Co., Ltd.

Substantially Equivalent

510(k) numberK152535

Submission

Device name
Z5 Slit lamp microscope, Z2 Slit lamp microscope
Applicant
Takagi Seiko Co., Ltd.
Nakano, JP
Received
September 4, 2015
Decision date
May 26, 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
HJO – Biomicroscope, Slit-Lamp, Ac-Powered
Device class
Class II (moderate risk)
Regulation
21 CFR 886.1850
Specialty
Ophthalmic

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Questions and answers

When was Z5 Slit lamp microscope, Z2 Slit lamp microscope cleared by the FDA?

Z5 Slit lamp microscope, Z2 Slit lamp microscope (K152535) received a 510(k) decision of Substantially Equivalent on May 26, 2016, 265 days after the submission was received.

What is the product code of K152535?

The FDA product code is HJO – Biomicroscope, Slit-Lamp, Ac-Powered, a Class II (moderate risk) device regulated under 21 CFR 886.1850.