Cleared Traditional

K000327 - WAVESCAN WAVEFRONT SYSTEM MODEL HS 1

K000327 is an FDA 510(k) clearance for WAVESCAN WAVEFRONT SYSTEM MODEL HS 1, manufactured by Visx, Incorporated. The device is a Class 1 Ophthalmic device with product code HKO cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K000327 · Visx, Incorporated · Ophthalmic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
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.

FDA 510(k) Submission Details - K000327

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
20d faster than avg
Panel avg: 110d · This submission: 90d
Pathway characteristics
Predicate-based equivalence.

HKO Device Classification - Class 1, General Controls

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.

Regulatory Peers - HKO Refractometer, Ophthalmic

All 31
Devices cleared under the same product code (HKO) and FDA review panel - the closest regulatory comparables to K000327.
TOPCON MODEL BV-1000 AUTOMATED SUBJECTIVE REFRACTION SYSTEM
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K945959 · Tomey Corporation USA · Mar 1995
AUTO REF-KERATOMETER, RK-3
K942242 · Cannon U.S.A., Inc. · Sep 1994
AUTO REFF-30
K940516 · Canon, Inc. · Jul 1994
AUTOREF LENSMETER RL-10
K925304 · Canon USA, Inc. · Feb 1994
K000327 · WAVESCAN WAVEFRONT SYSTEM MODEL HS 1
Download PDF FDA Summary Visx, Incorporated