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FDA 510(k)

ARGON/KRYPTON LASER PHOTOCOAGULATOR SYS

K-Number: K843966 · 1984-11-08

ApplicantAmerican Medical Optics
Decision Date1984-11-08
Product CodeHQB
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

ARGON/KRYPTON LASER PHOTOCOAGULATOR SYS is the device name listed in this FDA 510(k) record. The listed applicant is American Medical Optics. It received FDA 510(k) clearance on 1984-11-08 under 510(k) number K843966. 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 ARGON/KRYPTON LASER PHOTOCOAGULATOR SYS?

ARGON/KRYPTON LASER PHOTOCOAGULATOR SYS is a medical device that received FDA 510(k) clearance on 1984-11-08. The listed applicant is American Medical Optics. The 510(k) number is K843966.

When did ARGON/KRYPTON LASER PHOTOCOAGULATOR SYS receive FDA 510(k) clearance?

ARGON/KRYPTON LASER PHOTOCOAGULATOR SYS received FDA 510(k) clearance on 1984-11-08, under 510(k) number K843966.

Who is the listed applicant for ARGON/KRYPTON LASER PHOTOCOAGULATOR SYS?

The FDA 510(k) record lists American Medical Optics as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ARGON/KRYPTON LASER PHOTOCOAGULATOR SYS?

The FDA product code for ARGON/KRYPTON LASER PHOTOCOAGULATOR SYS is HQB.

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Other records listing American Medical Optics 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.

K860001BARRAQUER-KRUMEICH REFRACTIVE SETK851264AMER. MEDICAL OPTICS MONOCULAR INDIRECT OPHTHALMASK851263AMER. MEDICAL OPTIC MONOCULAR DIRECT OPHTHALMASCOPK851262AMER. MEDICAL OPTICAL BINOCULAR INDIRECT OPHTHALMAK844150MEDICAL OPTICS PHACOEMULSIFICATION KITK843965ARGON LASER PHOTOCOAGULATOR SYS

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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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