Cleared Traditional

HP-OCT (HP-OCT)

K231760 · Cylite Pty. , Ltd. · Ophthalmic

Mar 2024

Decision

266d

Days

Class 2

Risk

About This 510(k) Submission

K231760 is an FDA 510(k) clearance for the HP-OCT (HP-OCT), a Biomicroscope, Slit-lamp, Ac-powered (Class II — Special Controls, product code HJO), submitted by Cylite Pty. , Ltd. (Mulgrave, AU). The FDA issued a Cleared decision on March 8, 2024, 266 days after receiving the submission on June 16, 2023. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.1850.

Submission Details

510(k) Number	K231760 FDA.gov
FDA Decision	Cleared SESE
Date Received	June 16, 2023
Decision Date	March 08, 2024
Days to Decision	266 days
Submission Type	Traditional
Review Panel	Ophthalmic (OP)
Summary	Summary PDF