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FDA 510(k)

SYNERGETICS DIRECTIONAL ENDOOCULAR LASER PROBE

K-Number: K113857 · 2012-04-23

ApplicantSynergetics, Inc.
Decision Date2012-04-23
Product CodeHQB
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

SYNERGETICS DIRECTIONAL ENDOOCULAR LASER PROBE is the device name listed in this FDA 510(k) record. The listed applicant is Synergetics, Inc.. It received FDA 510(k) clearance on 2012-04-23 under 510(k) number K113857. The device is classified under product code HQB. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SYNERGETICS DIRECTIONAL ENDOOCULAR LASER PROBE?

SYNERGETICS DIRECTIONAL ENDOOCULAR LASER PROBE is a medical device that received FDA 510(k) clearance on 2012-04-23. The listed applicant is Synergetics, Inc.. The 510(k) number is K113857.

When did SYNERGETICS DIRECTIONAL ENDOOCULAR LASER PROBE receive FDA 510(k) clearance?

SYNERGETICS DIRECTIONAL ENDOOCULAR LASER PROBE received FDA 510(k) clearance on 2012-04-23, under 510(k) number K113857.

Who is the listed applicant for SYNERGETICS DIRECTIONAL ENDOOCULAR LASER PROBE?

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

What is the FDA product code for SYNERGETICS DIRECTIONAL ENDOOCULAR LASER PROBE?

The FDA product code for SYNERGETICS DIRECTIONAL ENDOOCULAR LASER PROBE is HQB.

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Related Devices (Code: HQB)

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.

K220263Vortex Surgical Laser Probes, Vortex Surgical Illuminated Laser Probes, Vortex Surgical Endoilluminators, Vortex Surgical ChandeliersVortex Surgical, Inc.K191846MAXReach Laser ProbeVortex Surgical, Inc.K182646Vitreq disposable laser probes, light fibers and ChandelierVitreQ BVK132614PEREGRINE CURVED ILLUMINATING LASER PROBEPeregrine Surgical , Ltd.K12299723GA CURVED ILLUMINATING LASER PROBEPeregrine Surgical , Ltd.K122905PEREGRINE 23GA CURVED LASER PROBEPeregrine Surgical , Ltd.

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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