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FDA 510(k)

20G SMA LASER FIBER, MODEL LF100

K-Number: K050807 · 2005-09-21

ApplicantOphthalmed, LLC
Decision Date2005-09-21
Product CodeHQF
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

20G SMA LASER FIBER, MODEL LF100 is the device name listed in this FDA 510(k) record. The listed applicant is Ophthalmed, LLC. It received FDA 510(k) clearance on 2005-09-21 under 510(k) number K050807. The device is classified under product code HQF. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the 20G SMA LASER FIBER, MODEL LF100?

20G SMA LASER FIBER, MODEL LF100 is a medical device that received FDA 510(k) clearance on 2005-09-21. The listed applicant is Ophthalmed, LLC. The 510(k) number is K050807.

When did 20G SMA LASER FIBER, MODEL LF100 receive FDA 510(k) clearance?

20G SMA LASER FIBER, MODEL LF100 received FDA 510(k) clearance on 2005-09-21, under 510(k) number K050807.

Who is the listed applicant for 20G SMA LASER FIBER, MODEL LF100?

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 LF100?

The FDA product code for 20G SMA LASER FIBER, MODEL LF100 is HQF.

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.

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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.

K02169620G SMA LASER FIBER, MODEL LF20; 25G SMA LASER FIBER, MODEL LF25

Related Devices (Code: HQF)

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.

K252979Voyager DSLT (430840610)Belkin Vision, Ltd.K251507INTEGRE LIOQuantel MedicalK251772Navilas Laser System 577sl (156691)Od-Os GmbHK243014EyeQ nanoECPEyeq, Inc.K240615Leos Laser and Endoscopy SystemBeaver-Visitec International, Inc.K242397LYNX PhotocoagulatorNorlase Aps

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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