Cleared Traditional

K862518 - BAUSCH & LOMB VERTOMETER V-5 (FDA 510(k) Clearance)

Aug 1986
Decision
41d
Days
Class 1
Risk

K862518 is an FDA 510(k) clearance for the BAUSCH & LOMB VERTOMETER V-5. This device is classified as a Instrument, Measuring, Lens, Ac-powered (Class I - General Controls, product code HLM).

Submitted by Bausch & Lomb, Inc. (Rochester, US). The FDA issued a Cleared decision on August 11, 1986, 41 days after receiving the submission on July 1, 1986.

This device falls under the Ophthalmic FDA review panel. Regulated under 21 CFR 886.1425.

Submission Details

510(k) Number K862518 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 01, 1986
Decision Date August 11, 1986
Days to Decision 41 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary -

Device Classification

Product Code HLM - Instrument, Measuring, Lens, Ac-powered
Device Class Class I - General Controls
CFR Regulation 21 CFR 886.1425