Cleared Traditional

Applanation Tonometer HT-5000

K232143 · Huvitz Co., Ltd. · Ophthalmic

Oct 2023

Decision

96d

Days

Class 2

Risk

About This 510(k) Submission

K232143 is an FDA 510(k) clearance for the Applanation Tonometer HT-5000, a Tonometer, Manual (Class II — Special Controls, product code HKY), submitted by Huvitz Co., Ltd. (Anyang-Si, KR). The FDA issued a Cleared decision on October 23, 2023, 96 days after receiving the submission on July 19, 2023. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.1930.

Submission Details

510(k) Number	K232143 FDA.gov
FDA Decision	Cleared SESE
Date Received	July 19, 2023
Decision Date	October 23, 2023
Days to Decision	96 days
Submission Type	Traditional
Review Panel	Ophthalmic (OP)
Summary	Summary PDF