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FDA 510(k)

APLION TOPICAL CARE SYSTEM

K-Number: K091133 · 2009-05-20

ApplicantAplion Medical,Llc
Decision Date2009-05-20
Product CodeNAD
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

APLION TOPICAL CARE SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Aplion Medical,Llc. It received FDA 510(k) clearance on 2009-05-20 under 510(k) number K091133. The device is classified under product code NAD. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the APLION TOPICAL CARE SYSTEM?

APLION TOPICAL CARE SYSTEM is a medical device that received FDA 510(k) clearance on 2009-05-20. The listed applicant is Aplion Medical,Llc. The 510(k) number is K091133.

When did APLION TOPICAL CARE SYSTEM receive FDA 510(k) clearance?

APLION TOPICAL CARE SYSTEM received FDA 510(k) clearance on 2009-05-20, under 510(k) number K091133.

Who is the listed applicant for APLION TOPICAL CARE SYSTEM?

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

What is the FDA product code for APLION TOPICAL CARE SYSTEM?

The FDA product code for APLION TOPICAL CARE SYSTEM is NAD.

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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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