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FDA 510(k)

HEALITE II SYSTEM

K-Number: K113668 · 2012-06-19

ApplicantLutronic Corporation
Decision Date2012-06-19
Product CodeILY
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

HEALITE II SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Lutronic Corporation. It received FDA 510(k) clearance on 2012-06-19 under 510(k) number K113668. The device is classified under product code ILY. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HEALITE II SYSTEM?

HEALITE II SYSTEM is a medical device that received FDA 510(k) clearance on 2012-06-19. The listed applicant is Lutronic Corporation. The 510(k) number is K113668.

When did HEALITE II SYSTEM receive FDA 510(k) clearance?

HEALITE II SYSTEM received FDA 510(k) clearance on 2012-06-19, under 510(k) number K113668.

Who is the listed applicant for HEALITE II SYSTEM?

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

What is the FDA product code for HEALITE II SYSTEM?

The FDA product code for HEALITE II SYSTEM is ILY.

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Related Devices (Code: ILY)

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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