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FDA 510(k)

WAVESCAN WAVEFRONT SYSTEM MODEL HS 1

K-Number: K000327 · 2000-05-02

ApplicantVisx, Incorporated
Decision Date2000-05-02
Product CodeHKO
Advisory CommitteeOP
DecisionUnknown

Device Summary

WAVESCAN WAVEFRONT SYSTEM MODEL HS 1 is the device name listed in this FDA 510(k) record. The listed applicant is Visx, Incorporated. It received FDA 510(k) clearance on 2000-05-02 under 510(k) number K000327. The device is classified under product code HKO. It was reviewed by the OP advisory panel. FDA Decision: Unknown.

Frequently Asked Questions

What is the WAVESCAN WAVEFRONT SYSTEM MODEL HS 1?

WAVESCAN WAVEFRONT SYSTEM MODEL HS 1 is a medical device that received FDA 510(k) clearance on 2000-05-02. The listed applicant is Visx, Incorporated. The 510(k) number is K000327.

When did WAVESCAN WAVEFRONT SYSTEM MODEL HS 1 receive FDA 510(k) clearance?

WAVESCAN WAVEFRONT SYSTEM MODEL HS 1 received FDA 510(k) clearance on 2000-05-02, under 510(k) number K000327.

Who is the listed applicant for WAVESCAN WAVEFRONT SYSTEM MODEL HS 1?

The FDA 510(k) record lists Visx, Incorporated as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for WAVESCAN WAVEFRONT SYSTEM MODEL HS 1?

The FDA product code for WAVESCAN WAVEFRONT SYSTEM MODEL HS 1 is HKO.

Related Clinical Trials

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Other records listing Visx, Incorporated as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K043503VISX CUSTOMVUE SLIT ILLUMINATOR WITH DESKTOP CHARGER, MODEL CV SI-1

Related Devices (Code: HKO)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K031831TOPCON MODEL BV-1000 AUTOMATED SUBJECTIVE REFRACTION SYSTEMTopcon Medical Systems, Inc.K951179DIGITAL RETINOSCOPIC PHOTOMETERKudi Kalu, Inc.K945959VIDEO VISION ANALYZER (VIVA), VRB 100Tomey Corporation USAK942242AUTO REF-KERATOMETER, RK-3Cannon U.S.A., Inc.K940516AUTO REFF-30Canon, Inc.K925304AUTOREF LENSMETER RL-10Canon USA, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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