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FDA 510(k)

MEDICAL OPTICS PHACOEMULSIFICATION KIT

K-Number: K844150 · 1984-12-11

ApplicantAmerican Medical Optics
Decision Date1984-12-11
Product CodeHQC
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

MEDICAL OPTICS PHACOEMULSIFICATION KIT 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 1984-12-11 under 510(k) number K844150. The device is classified under product code HQC. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MEDICAL OPTICS PHACOEMULSIFICATION KIT?

MEDICAL OPTICS PHACOEMULSIFICATION KIT is a medical device that received FDA 510(k) clearance on 1984-12-11. The listed applicant is American Medical Optics. The 510(k) number is K844150.

When did MEDICAL OPTICS PHACOEMULSIFICATION KIT receive FDA 510(k) clearance?

MEDICAL OPTICS PHACOEMULSIFICATION KIT received FDA 510(k) clearance on 1984-12-11, under 510(k) number K844150.

Who is the listed applicant for MEDICAL OPTICS PHACOEMULSIFICATION KIT?

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 MEDICAL OPTICS PHACOEMULSIFICATION KIT?

The FDA product code for MEDICAL OPTICS PHACOEMULSIFICATION KIT is HQC.

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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 OPHTHALMAK843966ARGON/KRYPTON LASER PHOTOCOAGULATOR SYSK843965ARGON LASER PHOTOCOAGULATOR SYS

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Related Devices (Code: HQC)

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.

K261264Stellaris Elite™ vision enhancement system; Posterior and Combined Procedure Pack(s): 23 ga. Posterior Elite™ Pack (SE5423); 23 ga. Bi-Blade™ Vitreous Cutter Posterior Stellaris Elite™ Pack (SE5423B); 25 ga. Posterior Elite™ Pack (SE5425); 25 ga. Bi-Blade™ Vitreous Cutter Posterior Stellaris Elite™ Pack (SE5425B); 27 ga. Bi-Blade™ Vitreous Cutter Posterior Stellaris Elite™ Pack (SE5427B); 23 ga. Bi-Blade™+ Vitreous Cutter Posterior Stellaris Elite™ Pack (SE5423BB+); 25 ga. Bi-Blade™+Bausch and LombK252052Stellaris Elite™ vision enhancement system (BL11145, BL14455, BL15455, SE14565, SE15565, SE14565E, SE15565E)Bausch and Lomb, IncorporatedK250501System SophiThis AGK243395MICOR 700 with Auto I/ACarl Zeiss Meditec Cataract Technology, Inc.K242801MICOR 700 System (N/A); MICOR 700 drive (FG-50631); MICOR 700 extractor (FG-50621); MICOR 700 vitrector (FG-51185)Carl Zeiss Meditec Cataract Technology, Inc.K240169Stellaris Elite vision enhancement system (BL11145, BL14455, BL15455)Bausch and Lomb, Incorporated

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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