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FDA 510(k)

VELASHAPE

K-Number: K122579 · 2012-09-13

ApplicantSyneron Medical, Ltd.
Decision Date2012-09-13
Product CodeNUV
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

VELASHAPE is the device name listed in this FDA 510(k) record. The listed applicant is Syneron Medical, Ltd.. It received FDA 510(k) clearance on 2012-09-13 under 510(k) number K122579. 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 VELASHAPE?

VELASHAPE is a medical device that received FDA 510(k) clearance on 2012-09-13. The listed applicant is Syneron Medical, Ltd.. The 510(k) number is K122579.

When did VELASHAPE receive FDA 510(k) clearance?

VELASHAPE received FDA 510(k) clearance on 2012-09-13, under 510(k) number K122579.

Who is the listed applicant for VELASHAPE?

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

What is the FDA product code for VELASHAPE?

The FDA product code for VELASHAPE is NUV.

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Other records listing Syneron Medical, Ltd. 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.

K170370ULTRASHAPE POWER SYSTEMK163415SlimShape SystemK162163UltraShape SystemK161952UltraShape SystemK160896ULTRASHAPE POWER SYSTEMK120510TRANSCEND

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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

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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