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FDA 510(k)

XACT LENS INSERTER SYSTEM, MODELS 6MM, 7MM

K-Number: K082871 · 2009-07-09

ApplicantSis Ltd., Surgical Instrument Systems
Decision Date2009-07-09
Product CodeMSS
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

XACT LENS INSERTER SYSTEM, MODELS 6MM, 7MM is the device name listed in this FDA 510(k) record. The listed applicant is Sis Ltd., Surgical Instrument Systems. It received FDA 510(k) clearance on 2009-07-09 under 510(k) number K082871. The device is classified under product code MSS. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the XACT LENS INSERTER SYSTEM, MODELS 6MM, 7MM?

XACT LENS INSERTER SYSTEM, MODELS 6MM, 7MM is a medical device that received FDA 510(k) clearance on 2009-07-09. The listed applicant is Sis Ltd., Surgical Instrument Systems. The 510(k) number is K082871.

When did XACT LENS INSERTER SYSTEM, MODELS 6MM, 7MM receive FDA 510(k) clearance?

XACT LENS INSERTER SYSTEM, MODELS 6MM, 7MM received FDA 510(k) clearance on 2009-07-09, under 510(k) number K082871.

Who is the listed applicant for XACT LENS INSERTER SYSTEM, MODELS 6MM, 7MM?

The FDA 510(k) record lists Sis Ltd., Surgical Instrument Systems as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for XACT LENS INSERTER SYSTEM, MODELS 6MM, 7MM?

The FDA product code for XACT LENS INSERTER SYSTEM, MODELS 6MM, 7MM is MSS.

Related Clinical Trials

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Other records listing Sis Ltd., Surgical Instrument Systems 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: MSS)

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.

K261174RxSight® Insertion DeviceRxsight, Inc.K252540ACCUJECT Injector Set 2.1-1P (LP604590)Medicel AGK242389EyeGility™ Inserter for Preloaded enVista IOLsBausch & Lomb, IncorporatedK231106Accuject Refra Injector AR2900Medicel AGK231838RxSight® Insertion Device (63002)Rxsight, Inc.K231466RxSight Insertion DeviceRxsight, Inc.

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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