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FDA 510(k)

PHACOFRAGMENTATION SYSTEM MEGATRON

K-Number: K002031 · 2000-12-27

ApplicantAsclepion-Meditec AG
Decision Date2000-12-27
Product CodeHQC
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

PHACOFRAGMENTATION SYSTEM MEGATRON is the device name listed in this FDA 510(k) record. The listed applicant is Asclepion-Meditec AG. It received FDA 510(k) clearance on 2000-12-27 under 510(k) number K002031. 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 PHACOFRAGMENTATION SYSTEM MEGATRON?

PHACOFRAGMENTATION SYSTEM MEGATRON is a medical device that received FDA 510(k) clearance on 2000-12-27. The listed applicant is Asclepion-Meditec AG. The 510(k) number is K002031.

When did PHACOFRAGMENTATION SYSTEM MEGATRON receive FDA 510(k) clearance?

PHACOFRAGMENTATION SYSTEM MEGATRON received FDA 510(k) clearance on 2000-12-27, under 510(k) number K002031.

Who is the listed applicant for PHACOFRAGMENTATION SYSTEM MEGATRON?

The FDA 510(k) record lists Asclepion-Meditec AG as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PHACOFRAGMENTATION SYSTEM MEGATRON?

The FDA product code for PHACOFRAGMENTATION SYSTEM MEGATRON is HQC.

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Other records listing Asclepion-Meditec AG as applicant

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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

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

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