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FDA 510(k)

I-LIPO, MODELS A00-1238 (230V), A00-1239 (120V)

K-Number: K101366 · 2010-09-17

ApplicantChromogenex Technologies, Ltd.
Decision Date2010-09-17
Product CodeNUV
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

I-LIPO, MODELS A00-1238 (230V), A00-1239 (120V) is the device name listed in this FDA 510(k) record. The listed applicant is Chromogenex Technologies, Ltd.. It received FDA 510(k) clearance on 2010-09-17 under 510(k) number K101366. The device is classified under product code NUV. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the I-LIPO, MODELS A00-1238 (230V), A00-1239 (120V)?

I-LIPO, MODELS A00-1238 (230V), A00-1239 (120V) is a medical device that received FDA 510(k) clearance on 2010-09-17. The listed applicant is Chromogenex Technologies, Ltd.. The 510(k) number is K101366.

When did I-LIPO, MODELS A00-1238 (230V), A00-1239 (120V) receive FDA 510(k) clearance?

I-LIPO, MODELS A00-1238 (230V), A00-1239 (120V) received FDA 510(k) clearance on 2010-09-17, under 510(k) number K101366.

Who is the listed applicant for I-LIPO, MODELS A00-1238 (230V), A00-1239 (120V)?

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

What is the FDA product code for I-LIPO, MODELS A00-1238 (230V), A00-1239 (120V)?

The FDA product code for I-LIPO, MODELS A00-1238 (230V), A00-1239 (120V) is NUV.

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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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