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FDA 510(k)

20G SMA LASER FIBER, MODEL LF20; 25G SMA LASER FIBER, MODEL LF25

K-Number: K021696 · 2002-08-20

ApplicantOphthalmed, LLC
Decision Date2002-08-20
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

20G SMA LASER FIBER, MODEL LF20; 25G SMA LASER FIBER, MODEL LF25 is the device name listed in this FDA 510(k) record. The listed applicant is Ophthalmed, LLC. It received FDA 510(k) clearance on 2002-08-20 under 510(k) number K021696. The device is classified under product code GEX. It was reviewed by the SU advisory panel. Product code GEX falls under the category of Gastroenterology, which includes gastrointestinal diagnostic and therapeutic devices. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the 20G SMA LASER FIBER, MODEL LF20; 25G SMA LASER FIBER, MODEL LF25?

20G SMA LASER FIBER, MODEL LF20; 25G SMA LASER FIBER, MODEL LF25 is a medical device that received FDA 510(k) clearance on 2002-08-20. The listed applicant is Ophthalmed, LLC. The 510(k) number is K021696.

When did 20G SMA LASER FIBER, MODEL LF20; 25G SMA LASER FIBER, MODEL LF25 receive FDA 510(k) clearance?

20G SMA LASER FIBER, MODEL LF20; 25G SMA LASER FIBER, MODEL LF25 received FDA 510(k) clearance on 2002-08-20, under 510(k) number K021696.

Who is the listed applicant for 20G SMA LASER FIBER, MODEL LF20; 25G SMA LASER FIBER, MODEL LF25?

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

What is the FDA product code for 20G SMA LASER FIBER, MODEL LF20; 25G SMA LASER FIBER, MODEL LF25?

The FDA product code for 20G SMA LASER FIBER, MODEL LF20; 25G SMA LASER FIBER, MODEL LF25 is GEX. This falls under the Gastroenterology category.

Related Clinical Trials

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Other records listing Ophthalmed, LLC 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.

K05080720G SMA LASER FIBER, MODEL LF100

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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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