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FDA 510(k)

ARGON LASER PHOTOCOAGULATOR SYS

K-Number: K843965 · 1984-11-06

ApplicantAmerican Medical Optics
Decision Date1984-11-06
Product CodeHQF
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

ARGON 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 1984-11-06 under 510(k) number K843965. 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 ARGON LASER PHOTOCOAGULATOR SYS?

ARGON LASER PHOTOCOAGULATOR SYS is a medical device that received FDA 510(k) clearance on 1984-11-06. The listed applicant is American Medical Optics. The 510(k) number is K843965.

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

ARGON LASER PHOTOCOAGULATOR SYS received FDA 510(k) clearance on 1984-11-06, under 510(k) number K843965.

Who is the listed applicant for ARGON 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 LASER PHOTOCOAGULATOR SYS?

The FDA product code for ARGON LASER PHOTOCOAGULATOR SYS is HQF.

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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 KITK843966ARGON/KRYPTON LASER PHOTOCOAGULATOR SYS

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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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