Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

BTL 799-2L

K-Number: K190456 · 2019-07-05

ApplicantBTL Industries, Inc.
Decision Date2019-07-05
Product CodeNGX
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

BTL 799-2L is a medical device manufactured by BTL Industries, Inc.. It received FDA 510(k) clearance on 2019-07-05 under approval number K190456. The device is classified under product code NGX. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BTL 799-2L?

BTL 799-2L is a medical device that received FDA 510(k) clearance on 2019-07-05. It is manufactured by BTL Industries, Inc.. The 510(k) number is K190456.

When was BTL 799-2L approved by the FDA?

BTL 799-2L received FDA 510(k) clearance on 2019-07-05, under approval number K190456.

What company makes BTL 799-2L?

BTL 799-2L is manufactured by BTL Industries, Inc..

What is the FDA product code for BTL 799-2L?

The FDA product code for BTL 799-2L is NGX.

Other Devices by BTL Industries, Inc.

K162010HPM-6000U K160992HPM-6000 K161551TR-100 K152731XP1100 RF K163165AM-100 K163176Exilis XP II

View all 33 devices →

Related Devices (Code: NGX)

K152420AK Body Toning DeviceAk Beauty Enterprises, LLC K161974SLENDERTONE® Connect Abs, Type 570Bio-Medical Research, Ltd. K152480Revitive Medic; Revitive MV; Revitive LVActegy , Ltd. K151722Slim UP ULTRAAime Medical, Inc. K172876PowerDot PD-01MSmartmissimo Technologies Pte, Ltd. K172241Tyece OTC EMS System, Model EM35Tyece , 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.

↑