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FDA 510(k)

FLUID ISOLATION DEVICE

K-Number: K091915 · 2009-10-27

ApplicantLenstec, Inc.
Decision Date2009-10-27
Product CodeHQC
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

FLUID ISOLATION DEVICE is the device name listed in this FDA 510(k) record. The listed applicant is Lenstec, Inc.. It received FDA 510(k) clearance on 2009-10-27 under 510(k) number K091915. The device is classified under product code HQC. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FLUID ISOLATION DEVICE?

FLUID ISOLATION DEVICE is a medical device that received FDA 510(k) clearance on 2009-10-27. The listed applicant is Lenstec, Inc.. The 510(k) number is K091915.

When did FLUID ISOLATION DEVICE receive FDA 510(k) clearance?

FLUID ISOLATION DEVICE received FDA 510(k) clearance on 2009-10-27, under 510(k) number K091915.

Who is the listed applicant for FLUID ISOLATION DEVICE?

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

What is the FDA product code for FLUID ISOLATION DEVICE?

The FDA product code for FLUID ISOLATION DEVICE is HQC.

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Other records listing Lenstec, 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.

K161776Lenstec LC Injection systemK122848LENSTEC LC INJECTION SYSTEMK063802LENSTEC LC INJECTION SYSTEMK060533LENSTEC INTRAOCULAR LENS (IOL) INJECTION SYSTEMK050638LENSTEC INTRAOCULAR LENS (IOL) INJECTION SYSTEM FOR TETRAFLEX INTRAOCULAR LENSES

Related Devices (Code: HQC)

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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.

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