Slit Lamp, Models HS-5000, HS-5500 and HS-7500

FDA 510(k) K093639 · Huvitz Co., Ltd.

Substantially Equivalent

510(k) numberK093639

Submission

Device name
Slit Lamp, Models HS-5000, HS-5500 and HS-7500
Applicant
Huvitz Co., Ltd.
Tempe, AZ, US
Received
November 24, 2009
Decision date
December 3, 2009
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA
Third-party review
Yes

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 Slit Lamp, Models HS-5000, HS-5500 and HS-7500 cleared by the FDA?

Slit Lamp, Models HS-5000, HS-5500 and HS-7500 (K093639) received a 510(k) decision of Substantially Equivalent on December 3, 2009, 9 days after the submission was received.

What is the product code of K093639?

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