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FDA 510(k)

ACULUX, MODEL AX3001, AX3002

K-Number: K001223 · 2000-06-23

ApplicantAculux
Decision Date2000-06-23
Product CodeFQP
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

ACULUX, MODEL AX3001, AX3002 is the device name listed in this FDA 510(k) record. The listed applicant is Aculux. It received FDA 510(k) clearance on 2000-06-23 under 510(k) number K001223. The device is classified under product code FQP. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ACULUX, MODEL AX3001, AX3002?

ACULUX, MODEL AX3001, AX3002 is a medical device that received FDA 510(k) clearance on 2000-06-23. The listed applicant is Aculux. The 510(k) number is K001223.

When did ACULUX, MODEL AX3001, AX3002 receive FDA 510(k) clearance?

ACULUX, MODEL AX3001, AX3002 received FDA 510(k) clearance on 2000-06-23, under 510(k) number K001223.

Who is the listed applicant for ACULUX, MODEL AX3001, AX3002?

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

What is the FDA product code for ACULUX, MODEL AX3001, AX3002?

The FDA product code for ACULUX, MODEL AX3001, AX3002 is FQP.

Related Clinical Trials

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Related Devices (Code: FQP)

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.

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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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