Cleared Traditional

Nam illumination probe with chopper

K202670 · Oculight , Ltd. · Ophthalmic
Aug 2021
Decision
340d
Days
Class 2
Risk

About This 510(k) Submission

K202670 is an FDA 510(k) clearance for the Nam illumination probe with chopper, a Endoilluminator (Class II — Special Controls, product code MPA), submitted by Oculight , Ltd. (Seongnam-Si, KR). The FDA issued a Cleared decision on August 20, 2021, 340 days after receiving the submission on September 14, 2020. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 876.1500.

Submission Details

510(k) Number K202670 FDA.gov
FDA Decision Cleared SESE
Date Received September 14, 2020
Decision Date August 20, 2021
Days to Decision 340 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Summary PDF

Device Classification

Product Code MPA — Endoilluminator
Device Class Class II — Special Controls
CFR Regulation 21 CFR 876.1500

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