Cleared Traditional

WAVESCAN WAVEFRONT SYSTEM MODEL HS 1

K000327 · Visx, Incorporated · Ophthalmic
May 2000
Decision
90d
Days
Class 1
Risk

About This 510(k) Submission

K000327 is an FDA 510(k) clearance for the WAVESCAN WAVEFRONT SYSTEM MODEL HS 1, a Refractometer, Ophthalmic (Class I — General Controls, product code HKO), submitted by Visx, Incorporated (Santa Clara, US). The FDA issued a Cleared decision on May 2, 2000, 90 days after receiving the submission on February 2, 2000. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.1760.

Submission Details

510(k) Number K000327 FDA.gov
FDA Decision Cleared SESU
Date Received February 02, 2000
Decision Date May 02, 2000
Days to Decision 90 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Summary PDF

Device Classification

Product Code HKO — Refractometer, Ophthalmic
Device Class Class I — General Controls
CFR Regulation 21 CFR 886.1760

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