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FDA 510(k)

LED LIGHT SOURCE

K-Number: K093792 · 2010-03-18

ApplicantSunoptic Technologies, LLC
Decision Date2010-03-18
Product CodeFCW
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

LED LIGHT SOURCE is the device name listed in this FDA 510(k) record. The listed applicant is Sunoptic Technologies, LLC. It received FDA 510(k) clearance on 2010-03-18 under 510(k) number K093792. The device is classified under product code FCW. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LED LIGHT SOURCE?

LED LIGHT SOURCE is a medical device that received FDA 510(k) clearance on 2010-03-18. The listed applicant is Sunoptic Technologies, LLC. The 510(k) number is K093792.

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

LED LIGHT SOURCE received FDA 510(k) clearance on 2010-03-18, under 510(k) number K093792.

Who is the listed applicant for LED LIGHT SOURCE?

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

What is the FDA product code for LED LIGHT SOURCE?

The FDA product code for LED LIGHT SOURCE is FCW.

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Related Devices (Code: FCW)

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.

K123956POWER LED 175KARL STORZ Endoscopy-America, Inc.K123359OVS1 VIDEO SYSTEMOlive Medical Corp.K121724ENDOLIGHT LED 1.1 ENDOLIGHTLED 1.2Richard Wolf Medical Instruments Corp.K091968KARL STORZ LED NOVA 100 COLD LIGHT FOUNTAIN, MODELS 2016020, 20161020CKARL STORZ Endoscopy-America, Inc.K082813STRYKER LED LIGHTSOURCEStryker Corp.K081477LUXTEC MLX LIGHT SOURCEIntegra Luxtec, 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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