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FDA 510(k)

ALMA LASERS ACCENT B-SHAPE MASSAGER HANDPIECE/MODULE

K-Number: K082622 · 2009-01-12

ApplicantAlma Lasers , Ltd.
Decision Date2009-01-12
Product CodeNUV
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

ALMA LASERS ACCENT B-SHAPE MASSAGER HANDPIECE/MODULE is the device name listed in this FDA 510(k) record. The listed applicant is Alma Lasers , Ltd.. It received FDA 510(k) clearance on 2009-01-12 under 510(k) number K082622. 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 ALMA LASERS ACCENT B-SHAPE MASSAGER HANDPIECE/MODULE?

ALMA LASERS ACCENT B-SHAPE MASSAGER HANDPIECE/MODULE is a medical device that received FDA 510(k) clearance on 2009-01-12. The listed applicant is Alma Lasers , Ltd.. The 510(k) number is K082622.

When did ALMA LASERS ACCENT B-SHAPE MASSAGER HANDPIECE/MODULE receive FDA 510(k) clearance?

ALMA LASERS ACCENT B-SHAPE MASSAGER HANDPIECE/MODULE received FDA 510(k) clearance on 2009-01-12, under 510(k) number K082622.

Who is the listed applicant for ALMA LASERS ACCENT B-SHAPE MASSAGER HANDPIECE/MODULE?

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

What is the FDA product code for ALMA LASERS ACCENT B-SHAPE MASSAGER HANDPIECE/MODULE?

The FDA product code for ALMA LASERS ACCENT B-SHAPE MASSAGER HANDPIECE/MODULE is NUV.

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Other records listing Alma Lasers , 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.

K212073Alma Diode Tabletop LaserK203441The Alma Hybrid Laser SystemK170850Alma QK090571ALMA LASERS ALEX755 MODULEK083848ALMA LASERS SOPRANO XL MULTI-APPLICATION PLATFORMK080463ALMA LASERS THERMOXEL CO2 LASER SYSTEM AND DELIVERY DEVICE ACCESSORIES

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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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