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FDA 510(k)

I.V.E. REFRACTION SYSTEM

K-Number: K812896 · 1981-12-02

ApplicantBausch & Lomb, Inc.
Decision Date1981-12-02
Product CodeHKO
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

I.V.E. REFRACTION SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Bausch & Lomb, Inc.. It received FDA 510(k) clearance on 1981-12-02 under 510(k) number K812896. The device is classified under product code HKO. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the I.V.E. REFRACTION SYSTEM?

I.V.E. REFRACTION SYSTEM is a medical device that received FDA 510(k) clearance on 1981-12-02. The listed applicant is Bausch & Lomb, Inc.. The 510(k) number is K812896.

When did I.V.E. REFRACTION SYSTEM receive FDA 510(k) clearance?

I.V.E. REFRACTION SYSTEM received FDA 510(k) clearance on 1981-12-02, under 510(k) number K812896.

Who is the listed applicant for I.V.E. REFRACTION SYSTEM?

The FDA 510(k) record lists Bausch & Lomb, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for I.V.E. REFRACTION SYSTEM?

The FDA product code for I.V.E. REFRACTION SYSTEM is HKO.

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Other records listing Bausch & Lomb, Inc. 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.

K192005Bausch + Lomb PreVue Inserter for enVista PreloadedK173480Crystalsert Lens Delivery SystemK161012Easy-Load Lens Delivery SystemK131208BAUSCH + LOMB PROCOMFORT (SAMFILCON A) CONTACT LENS, BAUSCH + LOMB PROCOMFORT (SAMFILCON A) CONTACT LENS FOR PRESBYOPIA,K122575BAUSCH & LOMB PUREVISION (BALAFILCON A) VISIBILITY TINTED CONTACT LENS, BAUSCH & LOMB PUREVISION TORIC (BALAFILCON A) VIK113852BAUSCH & LOMB IOL INJECTOR

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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.K000327WAVESCAN WAVEFRONT SYSTEM MODEL HS 1Visx, IncorporatedK951179DIGITAL RETINOSCOPIC PHOTOMETERKudi Kalu, Inc.K945959VIDEO VISION ANALYZER (VIVA), VRB 100Tomey Corporation USAK942242AUTO REF-KERATOMETER, RK-3Cannon U.S.A., Inc.K940516AUTO REFF-30Canon, 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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