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FDA 510(k)

SMOOTHSHAPES SYSTEM, 11318-120V, 11319-230V

K-Number: K100230 · 2010-04-02

ApplicantEleme Medical, Inc.
Decision Date2010-04-02
Product CodeNUV
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

SMOOTHSHAPES SYSTEM, 11318-120V, 11319-230V is the device name listed in this FDA 510(k) record. The listed applicant is Eleme Medical, Inc.. It received FDA 510(k) clearance on 2010-04-02 under 510(k) number K100230. 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 SMOOTHSHAPES SYSTEM, 11318-120V, 11319-230V?

SMOOTHSHAPES SYSTEM, 11318-120V, 11319-230V is a medical device that received FDA 510(k) clearance on 2010-04-02. The listed applicant is Eleme Medical, Inc.. The 510(k) number is K100230.

When did SMOOTHSHAPES SYSTEM, 11318-120V, 11319-230V receive FDA 510(k) clearance?

SMOOTHSHAPES SYSTEM, 11318-120V, 11319-230V received FDA 510(k) clearance on 2010-04-02, under 510(k) number K100230.

Who is the listed applicant for SMOOTHSHAPES SYSTEM, 11318-120V, 11319-230V?

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

What is the FDA product code for SMOOTHSHAPES SYSTEM, 11318-120V, 11319-230V?

The FDA product code for SMOOTHSHAPES SYSTEM, 11318-120V, 11319-230V is NUV.

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Other records listing Eleme Medical, Inc. as applicant

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.

K083478SMOOTHLIPOK083629SMOOTHSHAPES

Related Devices (Code: NUV)

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.

K261582Vacuum Roller RF Slimming Device for Medical Use (PZ-FY66-01, PZ-FY66-02)Zhengzhou PZ Laser Slim Technology Co., Ltd.K231092T-SHAPE 2B&M S.R.L. Marketing Nel BenessereK211272ICOONE Laser Med (also referred to as ICOONE Medical laser)I-Tech Industries SrlK182453ICOONE h (also referred to as ICOONE LASER and ICOONE –h LASER)I-Tech Industries SrlK161892Slimming Treatment DeviceBeijing Honkon Technologies Co., Ltd.K131362INMODE WMBODY DEVICEInmode MD , Ltd.

Official Source

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