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FDA 510(k)

Independent Corneal Viewing Chamber (IVC-21)

K-Number: K211786 · 2021-12-03

Decision Date2021-12-03
Product CodeLYX
DecisionSubstantially Equivalent

Device Summary

Independent Corneal Viewing Chamber (IVC-21) is the device name listed in this FDA 510(k) record. The listed applicant is Bausch + Lomb, Incorporated. It received FDA 510(k) clearance on 2021-12-03 under 510(k) number K211786. The device is classified under product code LYX. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Independent Corneal Viewing Chamber (IVC-21)?

Independent Corneal Viewing Chamber (IVC-21) is a medical device that received FDA 510(k) clearance on 2021-12-03. The listed applicant is Bausch + Lomb, Incorporated. The 510(k) number is K211786.

When did Independent Corneal Viewing Chamber (IVC-21) receive FDA 510(k) clearance?

Independent Corneal Viewing Chamber (IVC-21) received FDA 510(k) clearance on 2021-12-03, under 510(k) number K211786.

Who is the listed applicant for Independent Corneal Viewing Chamber (IVC-21)?

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

What is the FDA product code for Independent Corneal Viewing Chamber (IVC-21)?

The FDA product code for Independent Corneal Viewing Chamber (IVC-21) is LYX.

Related Clinical Trials

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.

Other records listing Bausch + Lomb, 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.

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Related Devices (Code: LYX)

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.

Official Source

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