Cleared Traditional

K924786 - BURTON TRIAL LENS SET
(FDA 510(k) Clearance)

Apr 1993
Decision
203d
Days
Class 1
Risk

K924786 is an FDA 510(k) clearance for the BURTON TRIAL LENS SET. This device is classified as a Set, Lens, Trial, Ophthalmic (Class I - General Controls, product code HPC).

Submitted by R.H. Burton Co. (Grove City, US). The FDA issued a Cleared decision on April 14, 1993, 203 days after receiving the submission on September 23, 1992.

This device falls under the Ophthalmic FDA review panel. Regulated under 21 CFR 886.1405.

Submission Details

510(k) Number K924786 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 23, 1992
Decision Date April 14, 1993
Days to Decision 203 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Statement

Device Classification

Product Code HPC — Set, Lens, Trial, Ophthalmic
Device Class Class I - General Controls
CFR Regulation 21 CFR 886.1405