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FDA 510(k)

MODIFIED ALMA LASERS FAMILY OF ACCENT RADIOFREQUENCY (RF) SYSTEM

K-Number: K101147 · 2011-01-21

ApplicantAlma Lasers, Inc.
Decision Date2011-01-21
Product CodeNUV
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

MODIFIED ALMA LASERS FAMILY OF ACCENT RADIOFREQUENCY (RF) SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Alma Lasers, Inc.. It received FDA 510(k) clearance on 2011-01-21 under 510(k) number K101147. 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 MODIFIED ALMA LASERS FAMILY OF ACCENT RADIOFREQUENCY (RF) SYSTEM?

MODIFIED ALMA LASERS FAMILY OF ACCENT RADIOFREQUENCY (RF) SYSTEM is a medical device that received FDA 510(k) clearance on 2011-01-21. The listed applicant is Alma Lasers, Inc.. The 510(k) number is K101147.

When did MODIFIED ALMA LASERS FAMILY OF ACCENT RADIOFREQUENCY (RF) SYSTEM receive FDA 510(k) clearance?

MODIFIED ALMA LASERS FAMILY OF ACCENT RADIOFREQUENCY (RF) SYSTEM received FDA 510(k) clearance on 2011-01-21, under 510(k) number K101147.

Who is the listed applicant for MODIFIED ALMA LASERS FAMILY OF ACCENT RADIOFREQUENCY (RF) SYSTEM?

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

What is the FDA product code for MODIFIED ALMA LASERS FAMILY OF ACCENT RADIOFREQUENCY (RF) SYSTEM?

The FDA product code for MODIFIED ALMA LASERS FAMILY OF ACCENT RADIOFREQUENCY (RF) SYSTEM is NUV.

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Other records listing Alma Lasers, 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.

K251684Alma TED+ SystemK250071Alma FemiLift Pixel CO2 Laser System, Delivery Devices and AccessoriesK251230The Alma Hybrid Laser SystemK243044Alma HarmonyK233024Alma HarmonyK230308Alma Harmony

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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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