Cleared Traditional

K791499 - RAY-BAN SUN GLASSES (FDA 510(k) Clearance)

Aug 1979
Decision
26d
Days
Class 1
Risk

K791499 is an FDA 510(k) clearance for the RAY-BAN SUN GLASSES. This device is classified as a Sunglasses (non-prescription Including Photosensitive) (Class I - General Controls, product code HQY).

Submitted by Bausch & Lomb, Inc. (Walker, US). The FDA issued a Cleared decision on August 28, 1979, 26 days after receiving the submission on August 2, 1979.

This device falls under the Ophthalmic FDA review panel. Regulated under 21 CFR 886.5850.

Submission Details

510(k) Number K791499 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 02, 1979
Decision Date August 28, 1979
Days to Decision 26 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary -

Device Classification

Product Code HQY - Sunglasses (non-prescription Including Photosensitive)
Device Class Class I - General Controls
CFR Regulation 21 CFR 886.5850