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FDA 510(k)

VISIAN NANOPOINT 2.0 INJECTOR MODEL LP604430

K-Number: K101134 · 2010-08-09

ApplicantMedicel AG
Decision Date2010-08-09
Product CodeMSS
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

VISIAN NANOPOINT 2.0 INJECTOR MODEL LP604430 is the device name listed in this FDA 510(k) record. The listed applicant is Medicel AG. It received FDA 510(k) clearance on 2010-08-09 under 510(k) number K101134. 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 VISIAN NANOPOINT 2.0 INJECTOR MODEL LP604430?

VISIAN NANOPOINT 2.0 INJECTOR MODEL LP604430 is a medical device that received FDA 510(k) clearance on 2010-08-09. The listed applicant is Medicel AG. The 510(k) number is K101134.

When did VISIAN NANOPOINT 2.0 INJECTOR MODEL LP604430 receive FDA 510(k) clearance?

VISIAN NANOPOINT 2.0 INJECTOR MODEL LP604430 received FDA 510(k) clearance on 2010-08-09, under 510(k) number K101134.

Who is the listed applicant for VISIAN NANOPOINT 2.0 INJECTOR MODEL LP604430?

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

What is the FDA product code for VISIAN NANOPOINT 2.0 INJECTOR MODEL LP604430?

The FDA product code for VISIAN NANOPOINT 2.0 INJECTOR MODEL LP604430 is MSS.

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Other records listing Medicel AG 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.

K252540ACCUJECT Injector Set 2.1-1P (LP604590)K231106Accuject Refra Injector AR2900K092023NAVIJECT SUB2-1P, MODEL: LP604430K070669IOL INJECTOR SETK040837MULTIJECT INJECTOR AND MICROGLIDE CARTRIDGE

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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