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FDA 510(k)

PLS PORTABLE LIGHT SOURCE

K-Number: K091829 · 2009-07-28

ApplicantOptim, Inc.
Decision Date2009-07-28
Product CodeNTN
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

PLS PORTABLE LIGHT SOURCE is the device name listed in this FDA 510(k) record. The listed applicant is Optim, Inc.. It received FDA 510(k) clearance on 2009-07-28 under 510(k) number K091829. The device is classified under product code NTN. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PLS PORTABLE LIGHT SOURCE?

PLS PORTABLE LIGHT SOURCE is a medical device that received FDA 510(k) clearance on 2009-07-28. The listed applicant is Optim, Inc.. The 510(k) number is K091829.

When did PLS PORTABLE LIGHT SOURCE receive FDA 510(k) clearance?

PLS PORTABLE LIGHT SOURCE received FDA 510(k) clearance on 2009-07-28, under 510(k) number K091829.

Who is the listed applicant for PLS PORTABLE LIGHT SOURCE?

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

What is the FDA product code for PLS PORTABLE LIGHT SOURCE?

The FDA product code for PLS PORTABLE LIGHT SOURCE is NTN.

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Optim, 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.

K080622ENTITY NASOVIEW LED NASOPHARYNGOSCOPE, MODEL 006105

Related Devices (Code: NTN)

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.

K130819CLL- V1 LIGHT SOURCEOlympus Winter & Ibe GmbHK122831VIDEO SYSTEM CENTEROlympus Medical Systems Corp.K113679LUCEA LED SURGICAL LIGHT SYSTEMMaquet S.A.S.K103813SOPRO 281SoproK102167LO-50 LED LIGHT SOURCEFiberoptics Technology, Inc.K090601FSC 2Schoelly Imaging, 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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