Cleared Traditional

WAVESCAN WAVEFRONT SYSTEM MODEL HS 1 (K000327) - FDA 510(k) Clearance

Class I Ophthalmic device.

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

K000327 is an FDA 510(k) clearance for the WAVESCAN WAVEFRONT SYSTEM MODEL HS 1. Classified as Refractometer, Ophthalmic (product code HKO), Class I - General Controls.

Submitted by Visx, Incorporated (Santa Ana, US). The FDA issued a Cleared decision on May 2, 2000 after a review of 90 days - within the typical 510(k) review window.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.1760 - the FDA ophthalmic device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Ophthalmic review framework, consistent with the majority of Class II 510(k) submissions.

View all Visx, Incorporated devices

Submission Details

510(k) Number K000327 FDA.gov
FDA Decision Cleared Substantially Equivalent - Abbreviated 510(k) (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
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
20d faster than avg
Panel avg: 110d · This submission: 90d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code HKO Refractometer, Ophthalmic
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 886.1760
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.